An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)
Sponsor study identifier
interventional
31
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 18, 2014
Actual (reported)April 22, 2014
Actual (reported)July 2014
Actual (reported)August 2014
Actual (reported)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
Safety and tolerability
Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects
Pro-inflammatory cytokines and biomarkers of bacterial translocation
28 days after receiving first dose of study drug
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.
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.
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.
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.
Clinical Pharmacology of Miami, Inc.
Fort Lauderdale, Florida, 33014, United States
Kenneth C Lasseter, MD
Clinical Pharmacology of Miami, Inc.
31 participants (actual enrollment reported by the registry).
First Submitted
April 18, 2014
First Posted
April 22, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
August 21, 2014
Record last verified: 2014-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: