A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05192369
- Lead Sponsor
- Concert Pharmaceuticals
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment B: Supratherapeutic Dose CTP-543 Single oral dose of 48mg CTP-543 Treatment A: Therapeutic Dose CTP-543 Single oral dose of 12mg CTP-543 Treatment D: Placebo Placebo Single oral dose of 1 Placebo tablet Treatment C: Positive Control Moxifloxacin Single oral dose of 400mg Moxifloxacin
- Primary Outcome Measures
Name Time Method TQT Analysis Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10 Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States