Parkinson DiseasePhase 1NCT04162275
A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China
A Phase 1 study testing Finamine tablets in people with Parkinson Disease, run by Yiling Pharmaceutical Inc. at 1 site in China.
Trial summary
Design：Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives： 1. To investigate the tolerability and safety of Chinese healthy adult subjects after a single oral administration of Finamine tablets; 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Finamine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2017to 27 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Shijiazhuang, Hebei, 050035
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- Finamine tablets, Placebo tablets
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finamine tabletsDrug
Also called Finamine tablet
taken Finamine tablets orally
Placebo tabletsDrug
taken Placebo tablets orally
| Study group | Role | What they receive |
|---|---|---|
| pre-trial, fasting administration | Experimental | 2 cases were given 150mg Finamine tablets（pre-trial，fasting administration） Receives: Drug: Finamine tablets |
| pre-trial,after high fat meal | Experimental | 2 cases were given 150mg Finamine tablets (pre- trial，after high fat meal) Receives: Drug: Finamine tablets |
| formal trial-150mg | Placebo comparator | 4 cases were given 150mg Finamine tablets 2 cases were given placebo Receives: Drug: Finamine tablets; Drug: Placebo tablets |
| formal trial-300mg | Placebo comparator | 6 cases were given 300mg Finamine tablets 2 cases were given placebo Receives: Drug: Finamine tablets; Drug: Placebo tablets |
| formal trial-600mg | Placebo comparator | 6 cases were given 600mg Finamine tablets 2 cases were given placebo Receives: Drug: Finamine tablets; Drug: Placebo tablets |
| formal trial-1200mg | Placebo comparator | 6 cases were given 1200mg Finamine tablets 2 cases were given placebo Receives: Drug: Finamine tablets; Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance evaluation
maximum tolerated dose（MTD）、dose-limiting toxicity（DLT）
Measured: From 0 to 96 hours after dosing
AE
The occurrence rate of AE.
Measured: 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.
Measured: From 0 to 96 hours after dosing
AUCinf
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Measured: From 0 to 96 hours after dosing
Peak Plasma Concentration (Cmax)
The PK parameters of the plasma sample.
Measured: From 0 to 96 hours after dosing
Tmax
The amount of time that a drug is present at the maximum concentration in serum.
Measured: From 0 to 96 hours after dosing
t1/2
The PK parameters of the plasma sample.
Measured: From 0 to 96 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start15 Aug 2017
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yiling Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162275
- Sponsor's protocol ID
- YLCDP-2015-010
- Status last verified
- Dec 2021
- First submitted
- 22 Sep 2019
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04162275
- Acronym / sponsor ID
- YLCDP-2015-010
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yiling Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| pre-trial, fasting administration | Experimental | Drug: Finamine tablets2 cases were given 150mg Finamine tablets（pre-trial，fasting administration） |
| pre-trial,after high fat meal | Experimental | Drug: Finamine tablets2 cases were given 150mg Finamine tablets (pre- trial，after high fat meal) |
| formal trial-150mg | Placebo comparator | Drug: Finamine tablets, Drug: Placebo tablets4 cases were given 150mg Finamine tablets 2 cases were given placebo |
| formal trial-300mg | Placebo comparator | Drug: Finamine tablets, Drug: Placebo tablets6 cases were given 300mg Finamine tablets 2 cases were given placebo |
| formal trial-600mg | Placebo comparator | Drug: Finamine tablets, Drug: Placebo tablets6 cases were given 600mg Finamine tablets 2 cases were given placebo |
| formal trial-1200mg | Placebo comparator | Drug: Finamine tablets, Drug: Placebo tablets6 cases were given 1200mg Finamine tablets 2 cases were given placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finamine tabletsAlso: Finamine tablettaken Finamine tablets orally | Drug | formal trial-1200mg, formal trial-150mg, formal trial-300mg, formal trial-600mg, pre-trial, fasting administration, pre-trial,after high fat meal |
| Placebo tabletstaken Placebo tablets orally | Drug | formal trial-1200mg, formal trial-150mg, formal trial-300mg, formal trial-600mg |
Primary outcome
Tolerance evaluation
Time frame: From 0 to 96 hours after dosing
maximum tolerated dose（MTD）、dose-limiting toxicity（DLT）
AE
Time frame: From 0 to 96 hours after dosing
The occurrence rate of AE.
AUC0-96h
Time frame: From 0 to 96 hours after dosing
area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing.
AUCinf
Time frame: From 0 to 96 hours after dosing
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Peak Plasma Concentration (Cmax)
Time frame: From 0 to 96 hours after dosing
The PK parameters of the plasma sample.
Tmax
Time frame: From 0 to 96 hours after dosing
The amount of time that a drug is present at the maximum concentration in serum.
t1/2
Time frame: From 0 to 96 hours after dosing
The PK parameters of the plasma sample.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Finamine tablets in people with Parkinson Disease, run by Yiling Pharmaceutical Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance evaluation (time frame: From 0 to 96 hours after dosing). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.