Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

• ClinicalTrials.gov Identifier: NCT03288636
• Recruitment Status: Completed
• First Posted: September 20, 2017
• Last Update Posted: January 17, 2018
• Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Information provided by (Responsible Party): Ascletis Pharmaceuticals Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HCV	Drug: Danoprevir; Drug: Ritonavir; Drug: Ravidasvir; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: August 8, 2017
• Actual Primary Completion Date: September 14, 2017
• Actual Study Completion Date: October 28, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental; PKGroup: Ravidasvir + Danoprevir/ Ritonavir	Drug: Danoprevir; Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23; Drug: Ritonavir; Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23; Drug: Ravidasvir; Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23; Other Name: ASC16(RDV)
Placebo Comparator: Placebo; Placebo Group: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events [ Time Frame: 40 days ]
   Incidence of adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China, Zhejiang

The first hospital of Zhejiang province

Hangzhou, Zhejiang, China, 310003

Sponsors and Collaborators

Ascletis Pharmaceuticals Co., Ltd.

More Information

• Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03288636
• Other Study ID Numbers: ASC-ASC16-I-CTP-02
• First Posted: September 20, 2017
• Last Update Posted: January 17, 2018
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ritonavir; HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors