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

Completed · Phase 1

Conditions studied: Liver Insufficiency

In brief

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.

Key facts

Study ID

NCT02120547

Run by

Tobira Therapeutics, Inc.

People needed

31

Starts

2014-03-01

Expected to finish

2014-08-01

Last updated by the study team

2014-08-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Clinical Pharmacology of Miami, Inc. — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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