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Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects

NCT05478772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-08-30

No results posted yet for this study

Summary

A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy subjects

Conditions

  • Health Volunteers

Interventions

DRUG

CTP-543

12 mg on Day 1 and Day 7

DRUG

Fluconazole

200 mg once daily on Days 3 through to Day 8

Sponsors & Collaborators

  • Concert Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2022-08-06
Completion
2022-08-12
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 NCT05478772 on ClinicalTrials.gov