Healthy Volunteers
Conditions
Keywords
Rifampin, Drug-drug interaction, CTP-543
Brief summary
This is a Phase 1 open-label study of the effect of rifampin on the pharmacokinetics of CTP-543 in healthy subjects.
Interventions
DRUGCTP-543
Rifampin as oral capsule
Sponsors
Concert Pharmaceuticals
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening * Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or 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 * 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 (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) * A positive test or history of incompletely treated or untreated tuberculosis * Donation of \> 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | 16 hours | Area Under the Plasma Concentration-Time Profile |
| AUC0-inf | 16 hours | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time |
| Cmax | 16 hours | Maximum observed concentration of drug in plasma |
| Tmax | 16 hours | Time to reach maximum observed concentration of drug in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 47 days | An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention |
Countries
United States
Outcome results
None listed