drugset / Trial / NCT03277755

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function

NCT03277755

Non-randomizedParallel-groupOpen-labelOther

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of AL-335, odalasvir (ODV) and its metabolites ALS-022399 and ALS-022227, after a single oral dose of ODV and AL-335 respectively, in participants with moderately impaired hepatic function compared to participants with normal hepatic function. Also to evaluate the steady-state PK of AL-335 and its metabolites ALS-022399 and ALS-022227, ODV and simeprevir (SMV) after multiple oral doses of the combination of AL-335+ODV+SMV, in participants with moderately impaired hepatic function compared to participants with normal hepatic function.

Timeline

Start
2017-09-11
Primary completion
2017-12-22
Completion
2017-12-22

Drugs

EvaluationDrugModalityDoseRoute
Subject ADAFOSBUVIR Small molecule 800 mg Oral
Subject Odalasvir Small molecule 25 mg Oral
Subject SMV Unknown 75 mg Oral

Indications

No indication recorded.