A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Ascletis

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis c

Treatments: Drug: Ravidasvir 50mg; Drug: Ravidasvir 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03430830

ASC-ASC16-I-CTP-03

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 6 patient groups

GROUP 1

Experimental group

Description:

1st 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.

Treatment:

Drug: Ravidasvir 200mg

Drug: Ravidasvir 50mg

GROUP 2

Experimental group

Description:

1st 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.

Treatment:

Drug: Ravidasvir 200mg

Drug: Ravidasvir 50mg

GROUP 3

Experimental group

Description:

1st 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.

Treatment:

Drug: Ravidasvir 200mg

Drug: Ravidasvir 50mg

GROUP 4

Experimental group

Description:

1st 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.

Treatment:

Drug: Ravidasvir 200mg

Drug: Ravidasvir 50mg

GROUP 5

Experimental group

Description:

1st 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.

Treatment:

Drug: Ravidasvir 200mg

Drug: Ravidasvir 50mg

GROUP 6

Experimental group

Description:

1st 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.

Treatment:

Drug: Ravidasvir 200mg

Drug: Ravidasvir 50mg