Clinical trial NCT03430830: A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis c
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-02-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: 27 days
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 27 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Yahong Chen, Master
role: STUDY_DIRECTOR
References:
citation: 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.