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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CTP-543
* Drug: CTP-543
* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking, adult males or females aged 18-60 Body mass index of 18 to 32 mg/m2 at Screening Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or Electrocardiograms (ECGs) If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication Understands the study procedures in the informed consent form and be willing and able to comply with the protocol Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing History of prolonged QT syndrome or a Corrected QT-interval (QTc) with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females obtained at Screening visit or prior to the first dosing Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug Positive results at Screening for human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus A positive test or history of incompletely treated or untreated tuberculosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: Therapeutic Dose<br>Single oral dose of 12mg CTP-543 | Drug: CTP-543<br>* CTP-543 12 mg (1 x 12 mg tablet), dosed with water<br>|
| Experimental: Treatment B: Supratherapeutic Dose<br>Single oral dose of 48mg CTP-543 | Drug: CTP-543<br>* CTP-543 48 mg (4 x 12 mg tablet) dosed with water<br>|
| Placebo Comparator: Treatment D: Placebo<br>Single oral dose of 1 Placebo tablet | Drug: Placebo<br>* Placebo (1 tablet) dosed with water<br>|
| Active Comparator: Treatment C: Positive Control<br>Single oral dose of 400mg Moxifloxacin | Drug: Moxifloxacin<br>* Moxifloxacin (1 x 400 mg tablet) dosed with water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TQT Analysis | Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint | Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTP-543