Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

NCT ID: NCT03288636

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-08
• Study Completion Date: 2017-10-28

Brief 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.

Conditions

HCV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

PKGroup:

Ravidasvir + Danoprevir/ Ritonavir

Group Type: EXPERIMENTAL

Danoprevir

Intervention Type: DRUG

Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Ritonavir

Intervention Type: DRUG

Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Ravidasvir

Intervention Type: DRUG

Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23

Placebo

Placebo Group:

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Danoprevir

Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Intervention Type: DRUG

Ritonavir

Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23

Intervention Type: DRUG

Ravidasvir

Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

ASC16(RDV)

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 19~28kg/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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first hospital of Zhejiang province

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34252301 (View on PubMed)

Other Identifiers

ASC-ASC16-I-CTP-02

Identifier Type: -

Identifier Source: org_study_id