Last reviewed · How we verify

NCT03288636

Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Completed Phase 1 Last updated 17 January 2018
What this trial tests

Phase 1 trial testing Danoprevir in HCV in 18 participants. Completed in 28 October 2017.

Timeline
8 August 2017
Primary endpoint
14 September 2017
28 October 2017

Quick facts

Lead sponsorAscletis Pharmaceuticals Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment18
Start date8 August 2017
Primary completion14 September 2017
Estimated completion28 October 2017
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Ascletis Pharmaceuticals Co., Ltd. — full company profile →

Who can join

Adults 18 to 45, any sex, with HCV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Progress, evolving therapeutic/diagnostic approaches, and challenges in the management of hepatitis C virus infections.
    Meshram RJ, Kathwate GH, Gacche RN. · · 2022 · cited 9× · PMID 35089390 · DOI 10.1007/s00705-022-05375-0
  2. Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects.
    Wu G, Zhou H, Wu J, Lv D, et al · · 2021 · cited 2× · PMID 34252301 · DOI 10.1128/aac.00600-21

Verify or expand the search:

Other trials of Danoprevir

Trials testing the same drug.

Other recruiting trials for HCV

Currently open trials in the same condition.

Other Ascletis Pharmaceuticals Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03288636.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing