NCT05192369

A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers

A Four-Arm, Randomized, Crossover, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Doses of CTP-543 on the QT/QTc Intervals in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CTP-543	CTP-543 12 mg (1 x 12 mg tablet), dosed with water
DRUG	CTP-543	CTP-543 48 mg (4 x 12 mg tablet) dosed with water
DRUG	Moxifloxacin	Moxifloxacin (1 x 400 mg tablet) dosed with water
DRUG	Placebo	Placebo (1 tablet) dosed with water

Timeline

• Start date: 2022-01-04
• Primary completion: 2022-01-28
• Completion: 2022-01-28
• First posted: 2022-01-14
• Last updated: 2022-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study