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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02120547

Enrollment

Registered

2014-04-22

Start date

2014-03-31

Completion date

2014-08-31

Last updated

2014-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Insufficiency

Keywords

Liver Insufficiency, Hepatic impairment

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.

Interventions

DRUGCenicriviroc in mild liver impaired

Subjects with mild hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.

DRUGCenicriviroc in moderate liver impaired

Subjects with moderate hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame
Pro-inflammatory cytokines and biomarkers of bacterial translocation	28 days after receiving first dose of study drug

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026