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OpenTrials
Completed

NCT Number: NCT03020134

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ravidasvir

Drug

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

Other names: ASC16(RDV)

Danoprevir

Drug

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)

Ritonavir

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 40 days

Secondary outcomes

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

    Time frame: Up to 24 weeks

  2. 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

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2017
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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