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drugset / Trial / NCT02821858

Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants

NCT02821858 ↗

Phase 1 Completed 40 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).

Timeline

Start
2016-06-14
Primary completion
2016-09-09
Completion
2016-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ADAFOSBUVIR Small molecule 400 mg Oral
Subject ADAFOSBUVIR Small molecule 800 mg Oral
Subject ADAFOSBUVIR Small molecule 1200 mg Oral
Subject Odalasvir Small molecule 50 mg Oral
Subject Odalasvir Small molecule 100 mg Oral
Subject Odalasvir Small molecule 300 mg Oral

Indications

No indication recorded.