Hepatic Impairment
Conditions
Keywords
Liver insufficiency, Hepatic Impairment, Cenicriviroc, Pharmacokinetics
Brief summary
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
Interventions
DRUGCenicriviroc
1 tablet; single-dose oral administration
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
for all participants: * Sign the ICF and have the mental capability to understand it * If female, have a negative result from a serum pregnancy test at screening and a negative result from a serum or urine pregnancy test on Day -1 * If male, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide or condom plus spermicide) and not have their partners become pregnant for at least 30 days after dosing study treatment, or have been sterilized for at least 1 year * If female of childbearing potential, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide, condom plus spermicide, or nonhormonal intrauterine device) and not become pregnant for at least 30 days after dosing study treatment. Females who are at least 2 years postmenopausal (with supporting documentation from an obstetrician/gynecologist) or who have had tubal ligation or hysterectomy (with supporting documentation from the physician who performed the surgery) will not be considered to be of childbearing potential * Be nonsmoking (never smoked or have not smoked in the previous 2 years) or a light smoker (fewer than 10 cigarettes per day within 1 week prior to study treatment administration) * Have a body mass index (BMI) ≥ 18 kg/m2 and ≤ 42 kg/m2 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: 1. Liver biopsy with histologic findings consistent with cirrhosis 2. Computerized tomographic or ultrasonographic evidence of liver disease with or without portal hypertension 3. Physical examination and clinical and laboratory evidence of chronic liver disease 4. 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)
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Total body clearance of drug from plasma (CL/F for CVC only) | 6 days (144 hours) |
| Terminal elimination half-life (T½) | 6 days (144 hours) |
| Volume of distribution during the terminal phase (Vz/F for CVC only) | 6 days (144 hours) |
| Time of maximum plasma drug concentration (Tmax) | 6 days (144 hours) |
| Terminal elimination rate constant | 6 days (144 hours) |
Countries
United States
Outcome results
None listed