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Completed

NCT Number: NCT03414294

A Study to Evaluate the Safety of K-755 in Healthy Volunteers

This is a Phase 1 study designed to explore the safety, tolerability and pharmacokinetics of K-755 following oral administration to healthy male and female volunteers.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX, Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
  • Males or females, of any race, between 18 and 45 years of age.
  • Body mass index (BMI) between 18.0 and 28.0 kg/m2.
  • Hematology, clinical chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.
  • No clinically significant abnormalities on the basis of medical history, physical examination findings, and vital signs.
  • All females must have a negative serum pregnancy test.
  • Able and willing to comply with the protocol and study procedures.

Exclusion criteria

  • Female subject who are pregnant or breastfeeding.
  • Subject with presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
  • Subject with any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-755.
  • Subject with presence of an active malignancy or within the past 5 years a malignancy of any type, other than basal cell carcinoma of the skin.
  • Subject has a history of type 1 hypersensitivity to any medication and/or clinically relevant food allergies.
  • Subject has a history of drug addiction.
  • Subject has a positive screen for drugs of abuse, cotinine or alcohol.
  • Subject has a history of regular alcohol consumption within 6 months of the study.
  • Subject has smoked tobacco within 6 months prior to Check-in, or has used non-inhaled tobacco- or nicotine-containing products within 3 months prior to Check-in.
  • Subject has used prescription or over-the-counter medications, dietary/nutritional supplements (except paracetamol or vitamin supplements)
  • Subject has used steroid medications (oral, inhaled, parenteral, or topical) within 30 days or 5 half-lives (whichever is longer) before study drug administration.
  • Subject has participated in an investigational drug study within 30 days or 5 half-lives (whichever is longer) before study drug administration.
  • Subject has a positive screen for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antigens/antibodies.
  • Subject has had a clinically significant acute illness within 4 weeks or other illness within 5 days before the first study drug administration.
  • Subject or a family member of the subject is a member of the professional or ancillary personnel working at the investigative site involved in the study.
  • Not suitable for entry into the study in the opinion of the Investigator.
  • Receipt of blood products within 2 months prior to Check-in.

Treatment and study plan

K-755 Part A (SAD)

Drug

Single ascending dose (SAD). There will be 7 cohorts in the Part A. Three quarters of subjects will receive K-755 tablet orally in a double-blind fashion.

Placebo Part A (SAD)

Drug

Single ascending dose (SAD). In Part A, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.

K-755 Part B (MAD)

Drug

Multiple ascending dose (MAD). There will be 4 cohorts in the Part B. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.

Placebo Part B (MAD)

Drug

Multiple ascending dose (MAD). In Part B, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.

K-755 Part C (FE)

Drug

Food effect (FE). All subjects in Part C will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.

K-755 Part D (FE)

Drug

Food effect (FE). All subjects in Part D will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.

K-755 Part E (MAD)

Drug

Multiple ascending dose (MAD). There will be 2 cohorts in the Part E. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.

Placebo Part E (MAD)

Drug

Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.

Primary outcomes

  1. Part A, B, C, D and E: Incidence and severity of Adverse Events

    Time frame: Up to 28 days after last administration

    A treatment-emergent adverse events (TEAE) will be summarized by treatment and overall, and summarized for each treatment by severity and relationship to study drug. All TEAEs leading to withdrawal, or SAEs, will be summarized.

  2. Part A, B, C, D and E: Number of subjects with clinical laboratory test abnormalities

    Time frame: Up to 28 days after last administration

    The clinical laboratory will include hematology (hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, platelet count, red blood cell count, white blood cell count), clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, cholesterol, creatinine, creatine phosphokinase, direct bilirubin, estimated glomerular filtration rate, gamma glutamyl transferase, glucose. inorganic phosphate, iron, lactate dehydrogenase, phosphorus, potassium, sodium, total bilirubin, total CO2, total protein, triglyceride, urea, uric acid), and urinalysis (bilirubin, blood, color and appearance, glucose, ketones, leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen, microscopic examination, electrolytes). Abnormality will be determined by the investigator.

  3. Part A, B, C, D and E: Number of subjects with vital signs abnormalities

    Time frame: Up to 28 days after last administration

    The vital sign will include blood pressure (mmHg), pulse rate (bpm), respiratory rate (breaths/min), and body temperature (degree Celsius). Abnormality will be determined by the investigator.

  4. Part A, B, C, D and E: Number of subjects with clinically significant change in body weight

    Time frame: Up to 28 days after last administration

    Change in body weight (kg) at baseline and post dose will be measured. Clinical significance will be determined by the investigator.

  5. Part A, B, C, D and E: Number of subjects with abnormal findings in physical examinations

    Time frame: Up to 28 days after last administration

    The physical examination will typically include general appearance, head and neck, eyes, ear, nose and throat, lymph nodes, thyroid, cardiovascular, respiratory, abdomen, nervous, skin, musculoskeletal, peripheral vascular and extremities and be performed at Investigator's discretion based on reported symptoms. Abnormality will be determined by the investigator.

Secondary outcomes

  1. Part A: AUC0-inf of K-755

    Time frame: Up to 28 days after single administration

    Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity

  2. Part A: AUC0-tlast of K-755

    Time frame: Up to 28 days after single administration

    AUC from time zero to the time of the last measurable concentration

  3. Part A: Cmax of K-755

    Time frame: Up to 28 days after single administration

    Maximum plasma concentration

  4. Part A: Tmax of K-755

    Time frame: Up to 28 days after single administration

    Time of the observed maximum plasma concentration

  5. Part A: t1/2 of K-755

    Time frame: Up to 28 days after single administration

    Terminal plasma elimination half-life

  6. Part B: AUC0-τ of K-755

    Time frame: Up to 28 days after repeated administration

    AUC over the dosing interval

  7. Part B: Cmax of K-755

    Time frame: Up to 28 days after repeated administration

    Maximum plasma concentration

  8. Part B: Tmax of K-755

    Time frame: Up to 28 days after repeated administration

    Time of the observed maximum plasma concentration

  9. Part B: t1/2 of K-755

    Time frame: Up to 28 days after repeated administration

    Terminal plasma elimination half-life

  10. Part C: AUC0-inf of K-755

    Time frame: Up to 14 days after single administration

    Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity

  11. Part C: AUC0-tlast of K-755

    Time frame: Up to 14 days after single administration

    AUC from time zero to the time of the last measurable concentration

  12. Part C: Cmax of K-755

    Time frame: Up to 14 days after single administration

    Maximum plasma concentration

  13. Part C: Tmax of K-755

    Time frame: Up to 14 days after single administration

    Time of the observed maximum plasma concentration

  14. Part C: t1/2 of K-755

    Time frame: Up to 14 days after single administration

    Terminal plasma elimination half-life

  15. Part D: AUC0-inf of K-755

    Time frame: Up to 14 days after single administration

    Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity

  16. Part D: AUC0-tlast of K-755

    Time frame: Up to 14 days after single administration

    AUC from time zero to the time of the last measurable concentration

  17. Part D: Cmax of K-755

    Time frame: Up to 14 days after single administration

    Maximum plasma concentration

  18. Part D: Tmax of K-755

    Time frame: Up to 14 days after single administration

    Time of the observed maximum plasma concentration

  19. Part D: t1/2 of K-755

    Time frame: Up to 14 days after single administration

    Terminal plasma elimination half-life

  20. Part E: AUC0-τ of K-755

    Time frame: Up to 14 days after single administration

    AUC over the dosing interval

  21. Part E: Cmax of K-755

    Time frame: Up to 14 days after single administration

    Maximum plasma concentration

  22. Part E: Tmax of K-755

    Time frame: Up to 14 days after single administration

    Time of the observed maximum plasma concentration

  23. Part E: t1/2 of K-755

    Time frame: Up to 14 days after single administration

    Terminal plasma elimination half-life

Sponsors and collaborators

Lead sponsor

Kowa Company, Ltd.

Industry

Registry information

Official study title

A Phase I Single-Center, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study to Investigate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of K-755 in Healthy Adult Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2018
Registry last updated
Jan 28, 2020

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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