NCT05467722

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

A Phase 1 Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of CTP-543 (Deuruxolitinib Phosphate)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	CTP-543	Single 12 mg oral dose administered on Day 1

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-09-15
• Completion: 2022-09-21
• First posted: 2022-07-20
• Last updated: 2022-11-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study