drugset / Trial / NCT02889367

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

NCT02889367

Phase 1 Completed 60 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindOther

Summary

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.

Timeline

Start
2016-09-12
Primary completion
2017-03-04
Completion
2017-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Odalasvir Small molecule 100 mg Oral
Subject Odalasvir Small molecule 500 mg Oral
Subject Odalasvir Small molecule 1000 mg Oral

Indications

No indication recorded.