Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China

NCT03020134 | Completed Phase 1 DMC

• 1 other identifier: ASC162002
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants

Conditions

Healthy

Keywords

pharmacokinetics; Danoprevir/r; Ravidasvir

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  40 days

Secondary Outcomes (2)

• Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)

  Up to 24 weeks

• Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state

  Up to 24 days

Study Arms (2)

PKGroup(Ravidasvir/Danoprevir/Ritonavir)

EXPERIMENTAL

Ravidasvir + Danoprevir/ Ritonavir

Drug: Ravidasvir; Drug: Danoprevir; Drug: Ritonavir

Placebo Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ravidasvir DRUG

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

Also known as: ASC16(RDV)

PKGroup(Ravidasvir/Danoprevir/Ritonavir)

Danoprevir DRUG

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

Also known as: ASC08 (DNV)

PKGroup(Ravidasvir/Danoprevir/Ritonavir)

Ritonavir DRUG

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

Also known as: RTV

PKGroup(Ravidasvir/Danoprevir/Ritonavir)

Placebo DRUG

Placebo

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent
• Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
• If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
• If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
• If female, negative pregnancy test during the screening period.
• Others as specified in the detailed protocol

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.
• Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
• History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
• Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
• Others as specified in the detailed protocol

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

MeSH Terms

Interventions

ravidasvir; danoprevir; Ritonavir

Intervention Hierarchy (Ancestors)

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

Study Officials

• Huoling Tang, PhD

  Ascletis Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 13, 2017
• Study Start: July 15, 2016
• Primary Completion: August 22, 2016
• Study Completion: August 22, 2016
• Last Updated: June 29, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share