Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites
- Registration Number
- NCT03376841
- Lead Sponsor
- Allergan
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Severe hepatic impairment Cenicriviroc Cenicriviroc tablet; single-dose oral administration Normal Hepatic function Cenicriviroc Cenicriviroc tablet; single-dose oral administration
- Primary Outcome Measures
Name Time Method Maximum plasma drug concentration (Cmax) 6 days (144 hours) AUC from time 0 to infinity (AUC0-∞) 6 days (144 hours) Area under the plasma concentration versus time curve (AUC) from time 0 to time t (AUC0-t) 6 days (144 hours)
- Secondary Outcome Measures
Name Time Method Time of maximum plasma drug concentration (Tmax) 6 days (144 hours) Terminal elimination rate constant 6 days (144 hours) Terminal elimination half-life (T½) 6 days (144 hours) Total body clearance of drug from plasma (CL/F for CVC only) 6 days (144 hours) Volume of distribution during the terminal phase (Vz/F for CVC only) 6 days (144 hours)
Trial Locations
- Locations (2)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Clinical Pharmacology of Miami
🇺🇸Miami, Florida, United States