Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites

Hepatic Impairment Clinical Trial

Official title:

An Open-Label Study to Evaluate the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Cenicriviroc and Its Metabolites Following Single Dose Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376841
• Other study ID #: 3152-102-002
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2017
• Last updated: January 9, 2018
• Start date: June 6, 2017
• Est. completion date: December 17, 2017

Study information

• Verified date: January 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 17, 2017
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Cenicriviroc
1 tablet; single-dose oral administration

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) from time 0 to time t (AUC0-t)		6 days (144 hours)
Primary	AUC from time 0 to infinity (AUC0-8)		6 days (144 hours)
Primary	Maximum plasma drug concentration (Cmax)		6 days (144 hours)
Secondary	Time of maximum plasma drug concentration (Tmax)		6 days (144 hours)
Secondary	Terminal elimination rate constant		6 days (144 hours)
Secondary	Terminal elimination half-life (T½)		6 days (144 hours)
Secondary	Total body clearance of drug from plasma (CL/F for CVC only)		6 days (144 hours)
Secondary	Volume of distribution during the terminal phase (Vz/F for CVC only)		6 days (144 hours)

External Links

•   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.