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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-04

Study Completion Date

2022-01-28

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment A: Therapeutic Dose

Single oral dose of 12mg CTP-543

Group Type EXPERIMENTAL

CTP-543

Intervention Type DRUG

CTP-543 12 mg (1 x 12 mg tablet), dosed with water

Treatment B: Supratherapeutic Dose

Single oral dose of 48mg CTP-543

Group Type EXPERIMENTAL

CTP-543

Intervention Type DRUG

CTP-543 48 mg (4 x 12 mg tablet) dosed with water

Treatment D: Placebo

Single oral dose of 1 Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (1 tablet) dosed with water

Treatment C: Positive Control

Single oral dose of 400mg Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Moxifloxacin (1 x 400 mg tablet) dosed with water

Interventions

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CTP-543

CTP-543 12 mg (1 x 12 mg tablet), dosed with water

Intervention Type DRUG

CTP-543

CTP-543 48 mg (4 x 12 mg tablet) dosed with water

Intervention Type DRUG

Moxifloxacin

Moxifloxacin (1 x 400 mg tablet) dosed with water

Intervention Type DRUG

Placebo

Placebo (1 tablet) dosed with water

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes