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

An Open-label Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Subjects With Moderately Impaired Hepatic Function

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	AL-335 800 mg	Participants will receive AL-335 800 mg (2 tablets of 400 mg AL-335) single oral dose on Day 1 of part 1 and in combination as AL-335 + ODV + SMV once daily orally from Day 1 to 14 of part 2.
DRUG	ODV 25 mg	Participants will receive ODV 25 mg (1 tablet of 25 mg ODV) single oral dose on Day 8 of part 1 and in combination as AL-335 + ODV + SMV once daily orally from Day 1 to 14 of part 2.
DRUG	SMV 75 mg	Participants will receive SMV 75 mg in combination as AL-335 + ODV + SMV once daily orally from Day 1 to 14 of part 2.

Timeline

• Start date: 2017-09-11
• Primary completion: 2017-12-22
• Completion: 2017-12-22
• First posted: 2017-09-11
• Last updated: 2017-10-11

Regulatory

• FDA-regulated drug study