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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-10

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Odalasvir 100 mg

Participants will receive odalasvir 2\*50 mg tablet, orally once on Day 1.

DRUG

Placebo

Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.

DRUG

Odalasvir 500 mg

Participants will receive odalasvir 10\*50 mg tablet, orally once on Day 1.

DRUG

Odalasvir (Up to maximum 1000 mg)

Participants will receive odalasvir to be decided up to maximum of 20\*50 mg tablet, orally once on Day 1.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2017-03-04
Completion
2017-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889367 on ClinicalTrials.gov