NCT03880136

Food Effect Study of CTP-543 in Healthy Volunteers

A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

Detailed description

This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CTP-543	Once daily dosing

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2019-03-19
• Last updated: 2019-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study