A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China

NCT04162275 | Completed Phase 1

• 1 other identifier: YLCDP-2015-010
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Design：Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives：

1. 1.To investigate the tolerability and safety of Chinese healthy adult subjects after a single oral administration of Finamine tablets;
2. 2.To investigate the pharmacokinetic (PK) characteristics of Finamine tablets;
3. 3.To provide dose setting basis for follow-up clinical studies. Investigational subject:Healthy-adult subjects in China

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (7)

• Tolerance evaluation

  maximum tolerated dose（MTD）、dose-limiting toxicity（DLT）

  From 0 to 96 hours after dosing

• AE

  The occurrence rate of AE.

  From 0 to 96 hours after dosing

• AUC0-96h

  area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing.

  From 0 to 96 hours after dosing

• AUCinf

  area under the concentration-time curve from the time of dosing extrapolated to time infinity.

  From 0 to 96 hours after dosing

• Peak Plasma Concentration (Cmax)

  The PK parameters of the plasma sample.

  From 0 to 96 hours after dosing

• Tmax

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

  From 0 to 96 hours after dosing

• t1/2

  The PK parameters of the plasma sample.

  From 0 to 96 hours after dosing

Study Arms (6)

pre-trial, fasting administration

EXPERIMENTAL

2 cases were given 150mg Finamine tablets（pre-trial，fasting administration）

Drug: Finamine tablets

pre-trial,after high fat meal

EXPERIMENTAL

2 cases were given 150mg Finamine tablets (pre- trial，after high fat meal)

Drug: Finamine tablets

formal trial-150mg

PLACEBO COMPARATOR

4 cases were given 150mg Finamine tablets 2 cases were given placebo

Drug: Finamine tablets; Drug: Placebo tablets

formal trial-300mg

PLACEBO COMPARATOR

6 cases were given 300mg Finamine tablets 2 cases were given placebo

Drug: Finamine tablets; Drug: Placebo tablets

formal trial-600mg

PLACEBO COMPARATOR

6 cases were given 600mg Finamine tablets 2 cases were given placebo

Drug: Finamine tablets; Drug: Placebo tablets

formal trial-1200mg

PLACEBO COMPARATOR

6 cases were given 1200mg Finamine tablets 2 cases were given placebo

Drug: Finamine tablets; Drug: Placebo tablets

Interventions

Finamine tablets DRUG

taken Finamine tablets orally

Also known as: Finamine tablet

formal trial-1200mg; formal trial-150mg; formal trial-300mg; formal trial-600mg; pre-trial, fasting administration; pre-trial,after high fat meal

Placebo tablets DRUG

taken Placebo tablets orally

formal trial-1200mg; formal trial-150mg; formal trial-300mg; formal trial-600mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 years old (including the upper and lower limits).
• Male or female
• Weight ≥50kg, BMI 18-28 kg/m2 (including the upper and lower limits).
• Understand and sign the informed consent form，able to understand the process and requirements of the study, and volunteer to participate in this study.

You may not qualify if:

• If being one of the following conditions, subjects cannot be selected
• There is a history of disease in heart, liver, kidney, respiratory system, digestive tract, nervous system, endocrine system, immune system, blood system, etc., that the investigator has determined to be clinically significant;
• Abnormalities are in vital signs, comprehensive physical examinations, laboratory tests, ECG examinations, etc., and they are considered clinically significant by the investigator;
• Any drug was taken within two weeks prior to dosing in the study , and the investigators believe that this condition may affect the assessment results of this study;
• There is an seriously allergic history of food and drug or hypersensitivity that the investigator has identified as clinically significant;
• There are positive results of serological tests (HBsAg, anti-HCV, anti-HIV, or TP-Ab) during screening;
• Within 1 years prior to the administration of the drug, the history of drinking or drug abuse, that the investigator believes it may affect the evaluation results of the study. Or, during screening, the alcohol breath test or the urine screening test is positive.
• Subjects cannot quit smoking or quit drinking during the study period or subjects' carbon monoxide breath test is ≥7ppm during the screening period (when the investigator thinks it necessary, it can be further confirmed by urine cotinine test);
• Subjects participated in any drug clinical trial within 3 months prior to study dosing;
• Subjects donated blood ≥400mL or 2 units within 3 months prior to study dosing;
• Subjects do not agree to avoid the use of tobacco ,alcoholic beverages or caffeinated beverages, or to avoid strenuous exercise and other factors that influence such as absorption, distribution, metabolism, and excretion of drugs during 24 hours before dosing in the trial and in the duration of the trial;
• Pregnant or breastfeeding women, or subjects who are tested positive for serum HCG before dosing in the trial, or who are unable or unwilling to take contraception approved by researchers during the study period as directed by the investigator;
• Subjects who, in the opinion of nvestigators, are not suitable for participating in this clinical study.

Sponsors & Collaborators

• Yiling Pharmaceutical Inc.: lead

Study Sites (1)

Shijiazhuang Yiling Pharmaceutical Co. Ltd

Shijiazhuang, Hebei, 050035, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: November 14, 2019
• Study Start: August 15, 2017
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

CN (1)