Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment

Phase 1

Completed

• Conditions: Liver Insufficiency
• Interventions: Drug: Cenicriviroc in moderate liver impaired; Drug: Cenicriviroc in mild liver impaired

• Registration Number: NCT02120547
• Lead Sponsor: Tobira Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-22
• Primary Completion: 2014-07
• Status Verified: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Males and non-pregnant, non-lactating females aged 18-65
• Weight ≥ 50.0 kg
• BMI 18.0 - 40.0 kg/m2
• Able to participate, and willing to give written informed consent and to comply with the study restrictions
• Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)

Exclusion Criteria

• Pregnant or lactating women and male partners of women who are pregnant or lactating
• Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
• QTcF > 450 msec for males and > 470 msec for females at Screening or Day -1
• Donation or loss of blood over 350 mL within 60 days prior to screening
• Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cenicriviroc in moderate liver impaired	Cenicriviroc in moderate liver impaired	Subjects with moderate liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days.
Cenicriviroc in mild liver impaired	Cenicriviroc in mild liver impaired	Subjects with mild liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects	Adverse events, concomitant medications, vital signs, 12-lead triplicate ECGs, clinical laboratory tests (chemistry, hematology, urinalysis) and physical examinations will be assessed.

Trial Locations

Locations (1)

Clinical Pharmacology of Miami, Inc.; 🇺🇸 Fort Lauderdale, Florida, United States