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



Status:Completed
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:5/5/2014
Start Date:March 2014
End Date:August 2014
Contact:Eric Lefebvre, MD
Email:elefebvre@tobiratherapeutics.com
Phone:650-351-5073

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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
We found this trial at
1
site
Clinical Pharmacology of Miami, Inc.
Fort Lauderdale, Florida 33014
?
mi
from
Fort Lauderdale, FL
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