Status:
COMPLETED
A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 volunte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05192369
Start Date
January 4 2022
End Date
January 28 2022
Last Update
March 4 2022
Active Locations (1)
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1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014