NCT03376841

Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites

An Open-Label Study to Evaluate the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Cenicriviroc and Its Metabolites Following Single Dose Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with severely impaired hepatic function compared with matched healthy participants following single-dose administration

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Cenicriviroc	1 tablet; single-dose oral administration

Timeline

• Start date: 2017-06-06
• Primary completion: 2017-11-24
• Completion: 2017-12-17
• First posted: 2017-12-19
• Last updated: 2018-01-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study