A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
NCT05192369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2022-03-04
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
- 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 (1 tablet) dosed with water
Sponsors & Collaborators
-
Concert Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-04
- Primary Completion
- 2022-01-28
- Completion
- 2022-01-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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