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Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543

NCT05467722 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-11-29

No results posted yet for this study

Summary

This is an open-label, single-dose, single-period, parallel group designed study to determine the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.

Conditions

  • Hepatic Impairment

Interventions

DRUG

CTP-543

Single 12 mg oral dose administered on Day 1

Sponsors & Collaborators

  • Concert Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-09-15
Completion
2022-09-21
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 NCT05467722 on ClinicalTrials.gov