Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment

NCT02120547 | Completed Phase 1

• 1 other identifier: TBR 652-1-121
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Insufficiency

Keywords

Liver Insufficiency; Hepatic impairment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety and tolerability

  Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects

Other Outcomes (1)

• Pro-inflammatory cytokines and biomarkers of bacterial translocation

  28 days after receiving first dose of study drug

Study Arms (2)

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.

Drug: Cenicriviroc in mild liver impaired

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.

Drug: Cenicriviroc in moderate liver impaired

Interventions

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.

Also known as: CVC

Cenicriviroc in mild liver impaired

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.

Also known as: CVC

Cenicriviroc in moderate liver impaired

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-lactating females aged 18-65
• Weight ≥ 50.0 kg
• BMI 18.0 - 40.0 kg/m2
• Able to participate, and willing to give written informed consent and to comply with the study restrictions
• Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)

You may not qualify if:

• Pregnant or lactating women and male partners of women who are pregnant or lactating
• Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
• QTcF \> 450 msec for males and \> 470 msec for females at Screening or Day -1
• Donation or loss of blood over 350 mL within 60 days prior to screening
• Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment

Sponsors & Collaborators

• Tobira Therapeutics, Inc.: lead

Study Sites (1)

Clinical Pharmacology of Miami, Inc.

Fort Lauderdale, Florida, 33014, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

cenicriviroc

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Kenneth C Lasseter, MD

  Clinical Pharmacology of Miami, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 22, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

US (1)