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NCT Number: NCT07594977

Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers

This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.

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Key information

Conditions

Chronic Cholecystitis Bile Duct Diseases Biliary Dyskinesia Biliary Tract Diseases Common Bile Duct Diseases Digestive System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location status: Recruiting

Location contact

Elena A Smolyarchuk, MD, PhD

CONTACT

[email protected]

+7 499 248 38 34

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary, personally signed ICF obtained prior to any study procedures;
  • Males and females aged 18 to 45 years (inclusive) of Caucasian race;
  • Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified in the protocol;
  • Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive);
  • Heart rate (HR) from 60 to 89 beats/min (inclusive);
  • Respiratory rate (RR) from 12 to 20 per 1 minute (inclusive);
  • Body temperature from 36.0°C to 36.9°C (inclusive);
  • Body mass index (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, with body weight ≥ 55 kg for males and ≥ 45 kg for females;
  • Commitment to adhere to highly effective contraceptive methods during the study participation period and for 30 days thereafter; documentation of negative urine pregnancy test for women of childbearing potential.

Noninclusion Criteria:

  • History of clinically significant allergic reactions;
  • Hypersensitivity to hymecromone and trimebutine and/or excipients included in the study drug in anamnesis;
  • Drug intolerance to hymecromone and trimebutine and/or excipients included in the study drug in the anamnesis;
  • Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption in the anamnesis;
  • Chronic diseases of the kidney, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary and immune systems, as well as skin, hematopoietic and visual organs;
  • History of GI surgery (except for appendectomy at least 1 year prior to screening);
  • Diseases/conditions that, in the opinion of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug;
  • Acute infectious diseases less than 4 weeks prior to screening;
  • Intake of drugs that have a significant effect on hemodynamics and drugs that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;
  • Regular intake of a medicine less than 2 weeks prior to screening and single intake of a medicine less than 7 days prior to screening (including over-the-counter medicines, vitamins, supplements, herbs);
  • Blood or plasma donation less than 3 months prior to screening;
  • Use of hormonal contraceptives (in women) less than 2 months prior to screening;
  • Use of depot injections of any medicine less than 3 months prior to screening;
  • Pregnancy or lactation period; positive pregnancy test for women of childbearing potential;
  • Women of childbearing potential who have had unprotected sexual intercourse with a non-sterilized male partner within 30 days prior to administration of the study drug;
  • Participation in another clinical trial less than 3 months prior to screening or concurrent with the present study;
  • Consumption of more than 10 units of alcohol per week during the month prior to study enrollment (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine, or 50 mL of spirits), or a history of alcoholism, drug dependence, or abuse of medicinal products;
  • Smoking more than 10 cigarettes per day currently, or a history of smoking the indicated number of cigarettes in the 6 months preceding screening; failure to agree to abstain from smoking for the duration of the hospital stay;
  • Consumption of alcohol, caffeine, and xanthine-containing products in the 7 days prior to taking the study drug;
  • Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort - 7 days before taking the study drug;
  • Dehydration due to diarrhea, vomiting, or other cause within the last 24 hours prior to taking the study drug;
  • Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens at screening;
  • Clinically significant abnormalities on electrocardiogram (ECG) in the medical history and/or at screening;
  • Positive urinalysis for narcotics and potent drugs at screening;
  • Positive breath alcohol vapor test at screening;
  • Scheduling a hospital stay during the study period, for any reason other than hospitalization required by this protocol;
  • Failure or inability to comply with protocol requirements, follow protocol procedures, diet and activity regimen.
  • Belonging to a vulnerable population, including: students enrolled in medical, pharmaceutical, or dental educational institutions, clinical and laboratory assistants, pharmaceutical company employees, military personnel and prisoners, persons residing in residential care facilities, low-income and unemployed, minorities, homeless, vagrants, refugees, persons in foster care, persons unable to consent, and law enforcement officers;
  • Any other condition that, in the judgement of the Investigator, would preclude the volunteer's enrollment in the study or could lead to premature withdrawal from the study, including adherence to fasting regimens or special diets (e.g., vegetarian, vegan, or sodium-restricted diets) or lifestyle factors (e.g., night-shift work or extreme physical exertion)

Exclusion criteria

  • Voluntary withdrawal of the subject from the study;
  • Failure to comply with protocol requirements by the volunteer (e.g., missing scheduled study procedures, unauthorized use of prohibited medications, or violation of dietary or lifestyle restrictions);
  • Occurrence of any event or condition during the study that, in the investigator's judgement, may compromise the volunteer's safety (e.g., hypersensitivity reactions);
  • Volunteers selected for participation in the study in violation of the inclusion/non-inclusion criteria;
  • Development of severe adverse event and/or a serious adverse event in a volunteer during the course of the study;
  • Volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;
  • Missing collection of 2 or more consecutive blood samples or 3 x or more blood samples during the same Study Period;
  • Occurrence of vomiting/diarrhea within 6 h after administration of study drug;
  • Positive urine test for narcotics and potent drugs;
  • Positive breath alcohol test;
  • Positive pregnancy test in women;
  • Occurrence of any other circumstance that precludes conduct of the study in accordance with the protocol.

Treatment and study plan

4-MUST

Drug

128 mg tablets containing trimebutine 4-methylumbelliferyl sulfate (4-MUST)

Other names: trimebutine 4-methylumbelliferyl sulfate

Primary outcomes

  1. Pharmacokinetics - Cmax

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Maximum plasma concentration (Cmax) of 4-MUST metabolites: trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  2. Pharmacokinetics - tmax

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Time to reach Cmax (tmax) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  3. Pharmacokinetics - AUC0-t

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  4. Pharmacokinetics - AUC0-inf

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  5. Pharmacokinetics - AUC ratio

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    The ratio of the area under the concentration-time curve over the observation time to the calculated area under the concentration-time curve from zero to infinity

  6. Pharmacokinetics - t1/2

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Elimination half-life (t1/2) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  7. Pharmacokinetics - kel

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Elimination constant (kel) of of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  8. Pharmacokinetics - MRT

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Mean residence time (MRT) of of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  9. Pharmacokinetics - Vd

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Volume of distribution of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  10. Pharmacokinetics - Cmax/AUC0-t

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    The ratio of the maximum concentration to the area under the concentration-time curve during the observation period

  11. Pharmacokinetics - f'

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    f' - relative bioavailability (AUC(0-t)(fed)/AUC(0- t)(fasting))

  12. Pharmacokinetics - f''

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    f'' is the relative absorption rate (Cmax(fed)/Cmax(fasting))

  13. Bioavailability - ratio of Cmax

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Ratio of geometric mean Cmax for trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide under fasted and fed conditions (with 90% confidence intervals)

  14. Bioavailability - ratio of AUC0-t

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Ratio of geometric mean AUC0-t for of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide under fasted and fed conditions (with 90% confidence intervals)

  15. Bioavailability - ratio of AUC0-inf

    Time frame: From 0 to 48 hours (days 1-3 and 8-10)

    Ratio of geometric mean AUC0-inf for of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide under fasted and fed conditions (with 90% confidence intervals)

  16. Pharmacokinetics (multiple dosing) - number of terminal timepoints

    Time frame: From 72 to 120 hours

    number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant of of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  17. Pharmacokinetics (multiple dosing) - Cmax

    Time frame: From 72 to 120 hours

    Maximum plasma concentration (Cmax) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  18. Pharmacokinetics (multiple dosing) - tmax

    Time frame: From 72 to 120 hours

    Time to reach Cmax (tmax) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  19. Pharmacokinetics (multiple dosing) - AUC0-t

    Time frame: From 72 to 120 hours

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  20. Pharmacokinetics (multiple dosing) - AUC0-inf

    Time frame: From 72 to 120 hours

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  21. Pharmacokinetics (multiple dosing) - AUCextr

    Time frame: From 72 to 120 hours

    Extrapolated AUC of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  22. Pharmacokinetics (multiple dosing) - t1/2

    Time frame: From 72 to 120 hours

    Elimination half-life (t1/2) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  23. Pharmacokinetics (multiple dosing) - kel

    Time frame: From 72 to 120 hours

    Elimination constant (kel) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  24. Pharmacokinetics (multiple dosing) - MRT

    Time frame: From 72 to 120 hours

    Mean residence time (MRT) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  25. Pharmacokinetics (multiple dosing) - Vd

    Time frame: From 72 to 120 hours

    Volume of distribution of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  26. Pharmacokinetics (multiple dosing) - CL

    Time frame: From 72 to 120 hours

    Clearance (CL) of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  27. Pharmacokinetics (multiple dosing) - Cmax,ss

    Time frame: From 0 to 72 hours

    Maximum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  28. Pharmacokinetics (multiple dosing) - tmax,ss

    Time frame: From 0 to 72 hours

    Time to reach maximum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  29. Pharmacokinetics (multiple dosing) - tmin,ss

    Time frame: From 0 to 72 hours

    Time to reach minimum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  30. Pharmacokinetics (multiple dosing) - Cmin,ss

    Time frame: From 0 to 72 hours

    Minimum plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  31. Pharmacokinetics (multiple dosing) - Cavg,ss

    Time frame: From 0 to 72 hours

    Average plasma concentration at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

  32. Pharmacokinetics (multiple dosing) - CL,ss

    Time frame: From 0 to 72 hours

    Clearance at steady state of trimebutine, N-desmethyltrimebutine, 3,4,5-trimethoxybenzoic acid, 4-methylumbelliferone sulfate, 4-methylumbelliferone and 4-methylumbelliferone glucuronide

Secondary outcomes

  1. Adverse event type

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.

  2. Adverse event frequency

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Number and frequency of adverse events registered during the study

  3. Adverse event severety

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Severity of adverse events registered during the study, assessed using the Common Terminology Criteria for Adverse Events (CTCAE)

  4. Drop-outs associated with adverse events

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug

  5. Physical examination results - cardiovascular system

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)

  6. Physical examination results - respiratory system

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)

  7. Physical examination results - digestive tract

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)

  8. Physical examination results - endocrine system

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)

  9. Physical examination results - musculoskeletal system

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)

  10. Physical examination results - nervous system

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)

  11. Physical examination results - sensory systems

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)

  12. Physical examination results - skin/visible mucous membranes

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)

  13. Physical examination results - genitourinary system

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    An assessment of the condition of the genitourinary system on physical examination (normal condition or list of abnormal conditions, if any)

  14. Safety and Tolerability: vital signs - systolic blood pressure

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Systolic blood pressure (SBP, mmHg)

  15. Safety and Tolerability: vital signs - diastolic blood pressure

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Diastolic blood pressure (DBP, mmHg)

  16. Safety and Tolerability: vital signs - heart rate

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Heart rate (HR, bpm)

  17. Safety and Tolerability: vital signs - respiratory rate

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Respiratory rate (breaths per minute)

  18. Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Body temperature (Celsius temperature scale)

  19. Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6): heart rate (beats per minute)

  20. Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6): PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)

  21. Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)

  22. Safety and Tolerability: 12-lead electrocardiogram (ECG) - QT interval

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QT interval (distance from the beginning of the QRS complex to the end of the T wave)

  23. Safety and Tolerability: clinical blood test - hemoglobin

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Hemoglobin (g/L)

  24. Safety and Tolerability: clinical blood test - hematocrit

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Hematocrit (%)

  25. Safety and Tolerability: clinical blood test - red blood cell count

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Red blood cell count (cells/L)

  26. Safety and Tolerability: clinical blood test - platelet count

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Platelet count (cells/L)

  27. Safety and Tolerability: clinical blood test - leukocyte count

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte count (cells/L)

  28. Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Erythrocyte sedimentation rate (mm/h)

  29. Safety and Tolerability: clinical blood test - myelocytes

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte formula (myelocytes, %)

  30. Safety and Tolerability: clinical blood test - band neutrophils

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte formula (band neutrophils, %)

  31. Safety and Tolerability: clinical blood test - segmented neutrophils

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte formula (segmented neutrophils, %)

  32. Safety and Tolerability: clinical blood test - eosinophils

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte formula (eosinophils, %)

  33. Safety and Tolerability: clinical blood test - basophils

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte formula (basophils, %)

  34. Safety and Tolerability: clinical blood test - monocytes

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte formula (monocytes, %)

  35. Safety and Tolerability: clinical blood test - lymphocytes

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Leukocyte formula (lymphocytes, %)

  36. Safety and Tolerability: blood chemistry - glucose

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Glucose concentration (mmol/L)

  37. Safety and Tolerability: blood chemistry - cholesterol

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Total cholesterol concentration (mmol/L)

  38. Safety and Tolerability: blood chemistry - total protein

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Total protein in blood serum (g/L)

  39. Safety and Tolerability: blood chemistry - bilirubin

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Total bilirubin concentration (micromol/L)

  40. Safety and Tolerability: blood chemistry - creatinine

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Creatinine concentration (micromol/L)

  41. Safety and Tolerability: blood chemistry - alkaline phosphatase

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Alkaline phosphatase activity (U/L)

  42. Safety and Tolerability: blood chemistry - alanine transaminase

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Alanine transaminase activity (U/L)

  43. Safety and Tolerability: blood chemistry - aspartate transaminase

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Aspartate transaminase activity (U/L)

  44. Safety and Tolerability: urinalysis - specific gravity

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Specific gravity of the urine

  45. Safety and Tolerability: urinalysis - color

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Color of the urine

  46. Safety and Tolerability: urinalysis - transparency

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Transparency of the urine

  47. Safety and Tolerability: urinalysis - pH

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    pH of the urine

  48. Safety and Tolerability: urinalysis - protein

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Protein concentration (g/L)

  49. Safety and Tolerability: urinalysis - glucose

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Glucose concentration (mmol/L)

  50. Safety and Tolerability: urinalysis - red blood cells

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Red blood cell content (number in sight)

  51. Safety and Tolerability: urinalysis - white blood cells

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    White blood cell content (number in sight)

  52. Safety and Tolerability: urinalysis - casts

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Presence of casts (Yes/No)

  53. Safety and Tolerability: urinalysis - mucus

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Presence of mucus (Yes/No)

  54. Safety and Tolerability: urinalysis - bacteria

    Time frame: From day -14 - day -1 (screening) to day 16 ± 1 (end of the study)

    Presence of bacteria (Yes/No)

Sponsors and collaborators

Lead sponsor

Valenta Pharm JSC

Industry

Registry information

Official study title

An Open-Label Study to Evaluate the Effect of Food on the Bioavailability of 4-MUST, 128 mg, Tablets and to Assess the Pharmacokinetics, Safety, and Tolerability Following Single and Multiple Dose Administration in Healthy Volunteers

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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