An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)

NCT02120547 Phase 1 COMPLETED

To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.

Details

Lead sponsor	Tobira Therapeutics, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	31
Start date	2014-03
Completion	2014-08

Conditions

• Liver Insufficiency

Interventions

• Cenicriviroc in mild liver impaired
• Cenicriviroc in moderate liver impaired

Primary outcomes

• Multiple-dose pharmacokinetics of CVC — 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14
  Intensive PK on Days 1 and 14. Trough PK on Days 3-13. Additional free (unbound) CVC will be assessed 2 hours and 24 hours postdose on Day 14.

Countries

United States