drugset
drugset / Trial / NCT03155893

A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants

NCT03155893 ↗

Phase 1 Completed 59 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindOther

Summary

The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT/QTc and PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy participants.

Timeline

Start
2017-05-12
Primary completion
2017-10-27
Completion
2017-10-27

Drugs

EvaluationDrugModalityDoseRoute
Subject ADAFOSBUVIR Small molecule 1200 mg Oral
Subject Odalasvir Small molecule 25 mg Oral
Subject Odalasvir Small molecule 100 mg Oral
Subject Simeprevir Small molecule 150 mg Oral

Indications

No indication recorded.