NCT02889367 is a Phase 1 clinical trial of Odalasvir 100 mg in Healthy, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT02889367?

NCT02889367 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT02889367?

Interventions in NCT02889367: Odalasvir 100 mg, Placebo, Odalasvir 500 mg, Odalasvir (Up to maximum 1000 mg).

Is NCT02889367 still recruiting?

NCT02889367 is currently completed. Last updated 10 April 2017.

Last reviewed 2017-04-10 · How we verify

NCT02889367

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants

Completed Phase 1 Last updated 10 April 2017

What this trial tests

Phase 1 trial testing Odalasvir 100 mg in Healthy in 60 participants. Completed in 4 March 2017.

Timeline

12 September 2016

Primary endpoint
4 March 2017

4 March 2017

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	60
Start date	12 September 2016
Primary completion	4 March 2017
Estimated completion	4 March 2017
Sites	1 location across United States

Drugs / interventions tested

Odalasvir 100 mg — full drug profile →
Placebo
Odalasvir 500 mg — full drug profile →
Odalasvir (Up to maximum 1000 mg) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02889367 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 10 April 2017

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/NCT02889367.

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