NCT05478772

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

A 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 of CTP-543 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	CTP-543	12 mg on Day 1 and Day 7
DRUG	Fluconazole	200 mg once daily on Days 3 through to Day 8

Timeline

• Start date: 2022-07-11
• Primary completion: 2022-08-06
• Completion: 2022-08-12
• First posted: 2022-07-28
• Last updated: 2022-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study