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

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CTP-543; Drug: Moxifloxacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05192369

CP543.1010

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 4 patient groups, including a placebo group

Treatment A: Therapeutic Dose

Experimental group

Description:

Single oral dose of 12mg CTP-543

Treatment:

Drug: CTP-543

Drug: CTP-543

Treatment B: Supratherapeutic Dose

Experimental group

Description:

Single oral dose of 48mg CTP-543

Treatment:

Drug: CTP-543

Drug: CTP-543

Treatment D: Placebo

Placebo Comparator group

Description:

Single oral dose of 1 Placebo tablet

Treatment:

Drug: Placebo

Treatment C: Positive Control

Active Comparator group

Description:

Single oral dose of 400mg Moxifloxacin

Treatment:

Drug: Moxifloxacin