A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
A Randomized, Open, Three-dose (100 mg, 200 mg and 300 mg) Duplicate Bifunctional Crossover and Fixed 200mg Continuous Dose Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after 3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2018
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2018
CompletedJune 29, 2018
January 1, 2018
3 months
January 10, 2018
June 27, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Peak plasma concentration (Cmax)
Pharmacokinetics (blood draws, pre- and post-dose)
27 days
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics (blood draws, pre- and post-dose)
27 days
Study Arms (6)
GROUP 1
EXPERIMENTAL1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 19th to 25th day： Ravidasvir 200mg administered orally once daily.
GROUP 2
EXPERIMENTAL1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
GROUP 3
EXPERIMENTAL1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
GROUP 4
EXPERIMENTAL1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: Ravidasvir 200mg administered orally once daily; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
GROUP 5
EXPERIMENTAL1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
GROUP 6
EXPERIMENTAL1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Age between 18-45 years old;
- Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the range of 19\~24kg/m2
- Healthy men or women based on history, physical examination, laboratory examination and ECG.
- no plan of pregnancy in at least six months, and willing to take effective measures to prevent contraception from the first time when the drug is administered till the last time the drug is administered within 30 days.
- Female has negative pregnancy tests at the screening stage.
- Voluntary to sign the informed consent.
You may not qualify if:
- Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
- Has a history of drug or food allergy.
- Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
- Laboratory tests out of normal range and judged by the investigators as clinically significant.
- Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
- Pregnant, lactating women and people who unwilling to take effective measures to prevent contraception.
- People who consumed pomelo, apple or orange and foods or drinks containing their extracted ingredients within 3 days of taking the drug.
- Any prescription or over-the-counter medications, herbs, and vitamins are required to be taken prior to or within the first month of taking the drug.
- Selected within the first 6 months of smoking, alcohol, drug abuse or history of drug abuse.
- Selected within the first 3 months had blood loss or blood donation of 200ml.
- Participate in other clinical trials within the first 3 months of the study and received other study drug treatment.
- In addition to the above, the investigators judged not suitable for participating in this clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310003, China
Related Publications (1)
Wu G, Zhou H, Wu J, Lv D, Wu L, Zhai Y, Lin M, Wu JJ, Shentu J. Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0060021. doi: 10.1128/AAC.00600-21. Epub 2021 Jul 12.
PMID: 34252301DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yahong Chen, Master
Ascletis Pharmaceuticals Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2018
First Posted
February 13, 2018
Study Start
January 15, 2018
Primary Completion
April 9, 2018
Study Completion
April 9, 2018
Last Updated
June 29, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share