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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Ravidasvir; Drug: Danoprevir; Drug: Ritonavir

• Registration Number: NCT03020134
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-15
• Primary Completion: 2016-08-22
• Study Completion: 2016-08-22
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Status Verified: 2017-11
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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

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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.
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Placebo
PKGroup(Ravidasvir/Danoprevir/Ritonavir)	Danoprevir	Ravidasvir + Danoprevir/ Ritonavir
PKGroup(Ravidasvir/Danoprevir/Ritonavir)	Ritonavir	Ravidasvir + Danoprevir/ Ritonavir
PKGroup(Ravidasvir/Danoprevir/Ritonavir)	Ravidasvir	Ravidasvir + Danoprevir/ Ritonavir

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	40 days

Secondary Outcome Measures

Name	Time	Method
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