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

NCT03376841 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-01-11

No results posted yet for this study

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

Conditions

  • Hepatic Impairment

Interventions

DRUG

Cenicriviroc

1 tablet; single-dose oral administration

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Surya Ayalasomayajula · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2017-11-24
Completion
2017-12-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376841 on ClinicalTrials.gov