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The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with severely impaired hepatic function compared with matched healthy participants following single-dose administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe hepatic impairment | Experimental | Cenicriviroc tablet; single-dose oral administration |
|
| Normal Hepatic function | Experimental | Cenicriviroc tablet; single-dose oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenicriviroc | Drug | 1 tablet; single-dose oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) from time 0 to time t (AUC0-t) | 6 days (144 hours) | |
| AUC from time 0 to infinity (AUC0-∞) | 6 days (144 hours) | |
| Maximum plasma drug concentration (Cmax) | 6 days (144 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum plasma drug concentration (Tmax) | 6 days (144 hours) | |
| Terminal elimination rate constant | 6 days (144 hours) | |
| Terminal elimination half-life (T½) |
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Inclusion Criteria for all participants:
Inclusion Criteria for Participants with Severely Impaired Hepatic Function:
Have chronic liver disease and/or cirrhosis documented by the presence of at least 1 of the following:
Liver biopsy with histologic findings consistent with cirrhosis
Computerized tomographic or ultrasonographic evidence of liver disease with or without portal hypertension
Physical examination and clinical and laboratory evidence of chronic liver disease
Colloid shift on a liver-spleen scan
Exclusion Criteria for all participants:
Known hypersensitivity to cenicriviroc and other chemokine receptor 2 and/or 5 (CCR2 and/or CCR5) antagonists such as maraviroc (CCR5 antagonist)
History of substance abuse within the previous 2 years
Dosing in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 30 days of study treatment administration
Participation in a blood or plasma donation program within 60 or 30 days, respectively, of study treatment administration
Consumption of caffeine within 48 hours prior to dosing; consumption of grapefruit containing products, vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), foods containing poppy seeds, and charbroiled meats within 14 days prior to dosing; or consumption of alcohol within 72 hours prior to dosing before study treatment administration
Employee, or immediate relative of an employee, of the sponsor, any of its affiliates or partners, or the study center
Previously taken cenicriviroc or previously participated in an investigational study of cenicriviroc
Pregnant or breastfeeding (female participants)
Exclusion Criteria for Participants with Severely Impaired Hepatic Function:
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| Name | Affiliation | Role |
|---|---|---|
| Surya Ayalasomayajula | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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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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| 6 days (144 hours) |
| Total body clearance of drug from plasma (CL/F for CVC only) | 6 days (144 hours) |
| Volume of distribution during the terminal phase (Vz/F for CVC only) | 6 days (144 hours) |
| Orlando |
| Florida |
| 32809 |
| United States |