Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

NCT03288636 | Completed Phase 1 DMC

• 1 other identifier: ASC-ASC16-I-CTP-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Incidence of adverse events

  40 days

Study Arms (2)

Experimental

EXPERIMENTAL

PKGroup: Ravidasvir + Danoprevir/ Ritonavir

Drug: Danoprevir; Drug: Ritonavir; Drug: Ravidasvir

Placebo

PLACEBO COMPARATOR

Placebo Group: Placebo

Drug: Placebo

Interventions

Danoprevir DRUG

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

Experimental

Ritonavir DRUG

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

Experimental

Ravidasvir DRUG

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

Also known as: ASC16(RDV)

Experimental

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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\~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The first hospital of Zhejiang province

Hangzhou, Zhejiang, 310003, China

Location

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: 34252301 DERIVED

MeSH Terms

Interventions

danoprevir; Ritonavir; ravidasvir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: September 20, 2017
• Study Start: August 8, 2017
• Primary Completion: September 14, 2017
• Study Completion: October 28, 2017
• Last Updated: January 17, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)