Healthy Volunteers
Conditions
Keywords
CTP-543
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
Interventions
DRUGCTP-543
CTP-543 12 mg (1 x 12 mg tablet), dosed with water
DRUGMoxifloxacin
Moxifloxacin (1 x 400 mg tablet) dosed with water
DRUGPlacebo
Placebo (1 tablet) dosed with water
Sponsors
Concert Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed