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

Tobira Therapeutics

Status and phase: Completed; Phase 1

Conditions: Liver Insufficiency

Treatments: Drug: Cenicriviroc in moderate liver impaired; Drug: Cenicriviroc in mild liver impaired

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120547

TBR 652-1-121

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

31 participants in 2 patient groups

Cenicriviroc in mild liver impaired

Experimental group

Description:

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.

Treatment:

Drug: Cenicriviroc in mild liver impaired

Cenicriviroc in moderate liver impaired

Experimental group

Description:

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.

Treatment:

Drug: Cenicriviroc in moderate liver impaired