Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

HCV Clinical Trial

Official title:

A Phase I Study to Assess the Pharmacokinetics and Safety of Single Dose of Ravidasvir and Danoprevir/r and Repeated Doses of Ravidasvir in Combination With Danoprevir/r in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288636
• Other study ID #: ASC-ASC16-I-CTP-02
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2017
• Last updated: January 14, 2018
• Start date: August 8, 2017
• Est. completion date: October 28, 2017

Study information

• Verified date: October 2017
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 28, 2017
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 19~28kg/m2

• Healthy men or women based on history, physical examination, laboratory examination and ECG.

• Female subjects should be surgically sterilized (bilateral tubal ligation, bilateral ovariectomy or hysterectomy); or are willing to use at least one of the following contraceptive methods within 30 days of the first administration of the study drug until the last administration: I Male partner vas deferens ligation; II. Non-hormonal contraceptive methods: intrauterine contraceptives, condoms, contraceptive sponges, septa, vaginal ring containing sizing gel or cream.

• Male subjects should be surgically sterilized; or are willing to use at least one of the following contraceptive methods within 30 days from the first administration of the study to the last administration: I. Female partners abstinence during the study period (including no donation): II. Compounds use hormonal contraceptives (oral, vaginal, parenteral or transdermal); III. Subjects and / or their female partners use non-hormonal contraceptive methods: condoms, contraceptive sponges, membranes, intrauterine devices, Fine gel or cream of the vaginal ring.

• If female, the pregnancy test result should be negative during the screening period.

• Voluntary to sign the informed consent.

Exclusion Criteria:

• History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor.

• A history of drug or food allergy.

• Positive test in any of the HBsAg?HCV Ab?HIV Ab and Syphilis Ab.

• Any of the AST?ALT?ALP?TBIL and DBIL exceed the upper limits of normal, or other laboratory test results exceeding the normal range and judged by the investigator to be clinically significant.

• History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.

• Female who were during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.

• Female partners were fertile and unwilling to take reliable contraceptive measures.

• Others as specified in the detailed protocol.

Related Conditions & MeSH terms

• HCV

Intervention

Drug:
• Danoprevir
Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
• Ritonavir
Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
• Ravidasvir
Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
• Placebo
Placebo

Locations

Country	Name	City	State
China	The first hospital of Zhejiang province	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Incidence of adverse events	40 days