Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 1/13/2018 |
Start Date: | June 6, 2017 |
End Date: | December 17, 2017 |
An Open-Label Study to Evaluate the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Cenicriviroc and Its Metabolites Following Single Dose Administration
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
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
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)
Exclusion Criteria for Participants with Severely Impaired Hepatic Function:
- Have an acute exacerbation of liver disease as indicated by worsening clinical signs
and/or laboratory tests within the 4 weeks before study treatment administration
- Have ascites that will require paracentesis within 1 week of dosing or during the
study period
- Have gastrointestinal hemorrhage due to esophageal varices, peptic ulcers or Mallory
Weiss Syndrome within 6 months before Day 1, unless banded and stable
- Have a Child-Pugh score of < 10
- Any clinical condition other than hepatic impairment or previous surgery that might
affect the absorption, distribution, biotransformation, or excretion of cenicriviroc
and its metabolites
We found this trial at
2
sites
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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