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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenicriviroc in mild liver impaired | Experimental | 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. |
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| Cenicriviroc in moderate liver impaired | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenicriviroc in mild liver impaired | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple-dose pharmacokinetics of CVC | 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. | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Adverse events, concomitant medications, vital signs, 12-lead triplicate ECGs, clinical laboratory tests (chemistry, hematology, urinalysis) and physical examinations will be assessed. | Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-inflammatory cytokines and biomarkers of bacterial translocation | 28 days after receiving first dose of study drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth C Lasseter, MD | Clinical Pharmacology of Miami, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Fort Lauderdale | Florida | 33014 | United States |
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| Cenicriviroc in moderate liver impaired | Drug | 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. |
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|
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C506967 | cenicriviroc |
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