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Completed

NCT Number: NCT04693039

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

1. To evaluate the safety and tolerability of Phenlarmide tablets in patients with Parkinson's disease in the early and middle stages. 2. To evaluate the pharmacokinetics of Phenlarmide tablets in patients with Parkinson's disease. 3. To explore the efficacy of Phenlarmide tablets in the treatment of early and mid-term Parkinson's disease.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chen Biao

Beijing, Beijing Municipality, 100053, China

About this study

  • Objective to evaluate the tolerance and safety of multiple administration of fenloramide tablets in patients with early and mid-term Parkinson's disease: To evaluate the adverse events of DLT and MTD, adverse reactions, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine), vital signs, 12 lead ECG and physical examination of fenloramide tablets in patients with early and mid-term Parkinson's disease .
  • Objective to evaluate the pharmacokinetics of fenloramide tablets in patients with Parkinson's disease in early and middle stages. The main PK parameters included Tmax, SS, Cmax, SS, cavg, SS, Ke, T1 / 2, Cl / F (only fenloramide prototype), VZ / F (only fenloramide prototype), auc0-24, SS, aucinf, SS, auc0 last, SS, AUC_ %Extrap, DF, etc.
  • Objective to explore the efficacy of fenloramide tablets in the treatment of early and mid-term Parkinson's disease, and to observe the changes of UPDRS and CGI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in the study;
  • over 30 years old and have no gender limit;
  • Patients diagnosed with Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 Edition);
  • Hoehn-Yahr grade ≤ 3;
  • The Unified Parkinson's disease scale (UPDRS) motor score (Part III) ≥ 10;
  • Not using anti Parkinson's disease drugs within 28 days before enrollment;
  • If the subjects are receiving dopamine receptor agonists (such as Pramipexole, etc.), anticholinergic drugs (such as Benzhexol Hydrochloride, etc.), monoamine oxidase B (MAO-B) inhibitors (such as Selegiline, Rasagiline, etc.), and N-methyl-D-aspartate (NMDA) receptor antagonists (such as Amantadine), they should stop using the drugs 28 days before the screening period;
  • Patients who had been treated with levodopa preparation (including levodopa compound preparation) for less than 6 months before screening, and had not received levodopa preparation treatment within 28 days before screening period.

Exclusion criteria

  • Atypical Parkinson's symptoms due to the use of drugs (such as Flunarizine, Metoclopramide), nervous system diseases, genetic metabolic diseases, encephalitis, cerebrovascular diseases or other degenerative diseases (such as progressive supranuclear paralysis);
  • Patients with dementia, active mental illness or hallucination, severe depression (Beck Depression Scale - Ⅱ ≥ 29 points at screening), or Mini-Mental State Examination (MMSE) < 25 points;
  • Those who have received neurosurgical operation or electrical stimulation (such as pallidotomy, thalamotomy, deep brain electrical stimulation, etc.);
  • Patients with clinically significant abnormal liver function were defined as total bilirubin > 1.5 times of the upper limit of normal value or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times of the upper limit of normal value;
  • Patients with clinically significant renal dysfunction: creatinine clearance rate (CCR) < 30 ml / min (using Cockcroft-Gault formula);
  • Patients with uncontrollable or severe cardiovascular diseases, including NYHA grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction, arrhythmia requiring treatment at the time of screening, and QTc interval prolongation more than 480ms, in 6 months before the first administration of trial drug;
  • There is a history of heart, liver, kidney, respiratory, digestive, endocrine, immune or blood system diseases considered by researchers to be serious;
  • During the screening period, the patients with HIV positive, HBV or HCV infection and syphilis infection were active;
  • Patients with malignant tumor within 5 years before screening were excluded from cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical operation and breast intraductal carcinoma in situ after radical operation;
  • There were significant food or drug allergy history or hypersensitivity reaction judged by researchers as having clinical significance;
  • Participants in any clinical trials within 3 months before administration of the study;
  • Pregnant or lactating women, or those whose serum hCG test is positive before trial administration, who are unable or unwilling to take contraceptive measures approved by the researcher during the study period and within 3 months after the end of the study according to the instructions of the researcher;
  • Those considered unsuitable by the researchers to participate in this clinical trial.

Treatment and study plan

Phenlarmide

Drug

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Other names: FLZ-150mg, FLZ-300mg, FLZ-600mg, FLZ-900mg

Placebo

Drug

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Other names: Placebo-150mg, Placebo-300mg, Placebo-600mg, Placebo-900mg

Primary outcomes

  1. the dose limiting toxicity (DLT)

    Time frame: through study completion, an average of 6 months

    The occurrence of Dose limiting toxicity.

  2. Tmax, ss

    Time frame: through study completion, an average of 6 months

    After administration, the time when the highest concentration of drug appeared in plasma

  3. Efficacy evaluation

    Time frame: through study completion, an average of 6 months

    explore the efficacy of fenolamide tablets in the treatment of early and middle stage Parkinson's disease, and observe the changes of UPDRS and CGI.

  4. maximum tolerable dose (MTD)

    Time frame: through study completion, an average of 6 months

    The occurrence of Maximum tolerable dose.

  5. adverse events

    Time frame: through study completion, an average of 6 months

    The occurrence rate of adverse events.

  6. adverse reactions

    Time frame: through study completion, an average of 6 months

    The occurrence rate of adverse reactions

  7. blood routine

    Time frame: through study completion, an average of 6 months

    Check whether the red blood cell system, white blood cell system and platelet system are normal

  8. blood biochemistry

    Time frame: through study completion, an average of 6 months

    The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected

  9. coagulation function

    Time frame: through study completion, an average of 6 months

    Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.

  10. urine routine

    Time frame: through study completion, an average of 6 months

    Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.

  11. stool routine

    Time frame: through study completion, an average of 6 months

    Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.

  12. Body temperature

    Time frame: through study completion, an average of 6 months

    One of the vital signs.

  13. 12 lead ECG

    Time frame: through study completion, an average of 6 months

    Evaluation of QT interval

  14. Blood pressure

    Time frame: through study completion, an average of 6 months

    Assess whether systolic blood pressure and diastolic blood pressure are normal.

  15. Heart rate

    Time frame: through study completion, an average of 6 months

    One of the vital signs.

  16. Breathing

    Time frame: through study completion, an average of 6 months

    Assess if breathing is normal

  17. Cmax, ss

    Time frame: through study completion, an average of 6 months

    The highest concentration of the drug in the plasma after administration

  18. Cavg, ss

    Time frame: through study completion, an average of 6 months

    The quotient of the area under the plasma concentration time curve divided by the interval time within a dose interval after the plasma concentration reaches the steady state.

  19. Ke

    Time frame: through study completion, an average of 6 months

    The ratio of the amount of compound eliminated from the body to the total amount in the body in unit time

  20. t1/2

    Time frame: through study completion, an average of 6 months

    The time required for the concentration of a drug to drop by half in an organism

  21. CL/F (fenoxamide prototype only)

    Time frame: through study completion, an average of 6 months

    The amount of a substance excreted by the kidney per minute

  22. Vz/F (fenoxamide prototype only)

    Time frame: through study completion, an average of 6 months

    After the drug reaches dynamic equilibrium in the body, the ratio of the drug dose in the body to the blood concentration is called the apparent distribution volume

  23. AUC0-24, ss

    Time frame: through study completion, an average of 6 months

    After administration, the area under the 0-24 hour time curve of blood concentration absorbed into human circulation

  24. AUCinf, ss

    Time frame: through study completion, an average of 6 months

    After administration, the area under the time curve of 0-infinity of the blood concentration absorbed into human circulation

  25. AUC0-last，ss

    Time frame: through study completion, an average of 6 months

    After administration, the area under the time curve of 0-the last accurately determined sample collection time of the blood concentration absorbed into human circulation

  26. AUC_%Extrap

    Time frame: through study completion, an average of 6 months

    the area under the curve that has been derived after extrapolation of Residual Area

  27. DF

    Time frame: through study completion, an average of 6 months

    The index reflecting the unbalanced situation of transportation in time

Sponsors and collaborators

Lead sponsor

Shijiazhuang Yiling Pharmaceutical Co. Ltd

Industry

Collaborators

  • Xuanwu Hospital, Beijing

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets in Patients With Parkinson's Disease in the Early and Middle Stages

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Jan 3, 2022

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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