Back to resultsA Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Finamine tablets
Placebo tablets
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
pre-trial, fasting administration
pre-trial,after high fat meal
formal trial-150mg
formal trial-300mg
formal trial-600mg
formal trial-1200mg
Arm Description
2 cases were given 150mg Finamine tablets（pre-trial，fasting administration）
2 cases were given 150mg Finamine tablets (pre- trial，after high fat meal)
4 cases were given 150mg Finamine tablets 2 cases were given placebo
6 cases were given 300mg Finamine tablets 2 cases were given placebo
6 cases were given 600mg Finamine tablets 2 cases were given placebo
6 cases were given 1200mg Finamine tablets 2 cases were given placebo
Outcomes
Primary Outcome Measures
Tolerance evaluation
maximum tolerated dose（MTD）、dose-limiting toxicity（DLT）
AE
The occurrence rate of AE.
AUC0-96h
area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing.
AUCinf
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Peak Plasma Concentration (Cmax)
The PK parameters of the plasma sample.
Tmax
The amount of time that a drug is present at the maximum concentration in serum.
t1/2
The PK parameters of the plasma sample.
Secondary Outcome Measures
Full Information
NCT ID
NCT04162275
First Posted
September 22, 2019
Last Updated
December 11, 2021
Sponsor
Yiling Pharmaceutical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04162275
Brief Title
A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China
Official Title
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yiling Pharmaceutical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Design：Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives：
To investigate the tolerability and safety of Chinese healthy adult subjects after a single oral administration of Finamine tablets;
To investigate the pharmacokinetic (PK) characteristics of Finamine tablets;
To provide dose setting basis for follow-up clinical studies. Investigational subject:Healthy-adult subjects in China
34 cases (including 4 cases of the pre- trial), of which the 150mg dose group is in the 4 cases of pre- trial (open, all accepted Finamine tablets orally, among whom, two receive it under fasting condition , and the other two receive it half an hour post a high-fat meal started). There are 6 cases in the formal trial (the subjects' ratio of investigational drug to placebo is 2:1). In all other dose groups, the subjects' ratio of investigational drug to placebo is 3:1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pre-trial, fasting administration
Arm Type
Experimental
Arm Description
2 cases were given 150mg Finamine tablets（pre-trial，fasting administration）
Arm Title
pre-trial,after high fat meal
Arm Type
Experimental
Arm Description
2 cases were given 150mg Finamine tablets (pre- trial，after high fat meal)
Arm Title
formal trial-150mg
Arm Type
Placebo Comparator
Arm Description
4 cases were given 150mg Finamine tablets 2 cases were given placebo
Arm Title
formal trial-300mg
Arm Type
Placebo Comparator
Arm Description
6 cases were given 300mg Finamine tablets 2 cases were given placebo
Arm Title
formal trial-600mg
Arm Type
Placebo Comparator
Arm Description
6 cases were given 600mg Finamine tablets 2 cases were given placebo
Arm Title
formal trial-1200mg
Arm Type
Placebo Comparator
Arm Description
6 cases were given 1200mg Finamine tablets 2 cases were given placebo
Intervention Type
Drug
Intervention Name(s)
Finamine tablets
Other Intervention Name(s)
Finamine tablet
Intervention Description
taken Finamine tablets orally
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
taken Placebo tablets orally
Primary Outcome Measure Information:
Title
Tolerance evaluation
Description
maximum tolerated dose（MTD）、dose-limiting toxicity（DLT）
Time Frame
From 0 to 96 hours after dosing
Title
AE
Description
The occurrence rate of AE.
Time Frame
From 0 to 96 hours after dosing
Title
AUC0-96h
Description
area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing.
Time Frame
From 0 to 96 hours after dosing
Title
AUCinf
Description
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Time Frame
From 0 to 96 hours after dosing
Title
Peak Plasma Concentration (Cmax)
Description
The PK parameters of the plasma sample.
Time Frame
From 0 to 96 hours after dosing
Title
Tmax
Description
The amount of time that a drug is present at the maximum concentration in serum.
Time Frame
From 0 to 96 hours after dosing
Title
t1/2
Description
The PK parameters of the plasma sample.
Time Frame
From 0 to 96 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Shijiazhuang Yiling Pharmaceutical Co. Ltd
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050035
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China
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