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OpenTrials
Completed

NCT Number: NCT04164121

A Clinical Study Trial of Phenlarmide in China

1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers. 2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers. 3. Provide basis for dosage setting for follow-up clinical research.

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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

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking union medical college hospital

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1)18-65 years old (including upper and lower limits);
  • 2)Men and women are not limited;
  • 3)Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits);
  • 4)Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.

Exclusion criteria

  • 1)There is a history of heart, liver, kidney, respiratory, digestive tract, nervous system, endocrine, immune or hematological diseases judged by researchers as having clinical significance;
  • 2)There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers;
  • 3)Any drug was taken within two weeks before the study was administered, and the researchers believe that this condition may affect the evaluation results of the study;
  • 4)There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant;
  • 5)The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening;
  • 6)One year before the study was administered, some researchers believed that alcohol or drug abuse history might affect the results of this study, or that alcohol breath test or urine drug screening test were positive during screening;
  • 7)Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage;
  • 8)Those who participated in any clinical trial within 3 months before administration;
  • 9)Those who donated blood more than 400 mL or 2 units within 3 months before administration;
  • 10)Do not agree to avoid the use of tobacco, alcohol or caffeine-containing beverages within 24 hours before and during the trial, or to avoid vigorous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism and excretion;
  • 11)Pregnant or lactating women, or those with positive serum HCG test before administration, or those who are unable or unwilling to adopt contraceptive measures approved by the researchers during the study period and within three months after the end of the study, as directed by the researchers;
  • 12)Researchers do not consider it suitable for participants in this clinical study.

Treatment and study plan

Phenlarmide Tablets

Drug

Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.

Other names: FLZ

Placebos

Drug

Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.

Other names: FLZ-Placebos

Primary outcomes

  1. Tolerance evaluation index

    Time frame: From 0 to 20 days after dosing

    maximum tolerated dose (MTD), dose limited toxicity (DLT)

  2. Tmax

    Time frame: From 0 to 168 hours after the first dose

    The amount of time that a drug is present at the maximum concentration in serum.

  3. Peak Plasma Concentration (Cmax)

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  4. t1/2

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  5. Vz/F

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  6. CL/F

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  7. Mean residence time (MRT) parameter

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  8. Kel

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  9. Area under the plasma concentration versus time curve (AUC0-∞)

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  10. AUC0-24

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  11. AUC0-72

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  12. AUC0-last

    Time frame: From 0 to 168 hours after the first dose

    The PK parameters of the plasma sample

  13. Tmax, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  14. Cmax, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  15. Cmin, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  16. Cavg, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  17. t1/2, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  18. AUC0-24, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  19. AUC0-72, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  20. AUC0-∞, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

  21. AUC0-last, ss

    Time frame: From 0 to 72 hours after the last dose

    The PK parameters of the plasma sample

Sponsors and collaborators

Lead sponsor

Yiling Pharmaceutical Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Dec 14, 2021

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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