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

June 27, 2018 updated by: Ascletis Pharmaceuticals Co., Ltd.

Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Placebo
Drug: Placebo
Placebo
Experimental: PKGroup(Ravidasvir/Danoprevir/Ritonavir)
Ravidasvir + Danoprevir/ Ritonavir
Drug: Ravidasvir
Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
Other Names:
  • ASC16(RDV)
Drug: Danoprevir
Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
Other Names:
  • ASC08 (DNV)
Drug: Ritonavir
Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
Other Names:
  • RTV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 40 days
40 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Time Frame: Up to 24 weeks
Up to 24 weeks
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
Time Frame: Up to 24 days
Up to 24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Investigators

  • Study Director: Huoling Tang, PhD, Ascletis Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2016

Primary Completion (Actual)

August 22, 2016

Study Completion (Actual)

August 22, 2016

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC162002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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