A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inducer, Rifampin, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects
| Registry | NCT04843540 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; na, sequential, masking: none, other |
| Enrollment | 22 (Actual) |
| Sponsor | Concert Pharmaceuticals (Industry) |
| Conditions | Healthy Volunteers |
| Interventions | CTP-543 (Drug) |
| Dates | start 2021-05-19, primary completion 2021-06-24, completion 2021-07-02, first posted 2021-04-13, last updated 2021-07-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Healthy Volunteers All trials of CTP-543
This is a Phase 1 open-label study of the effect of rifampin on the pharmacokinetics of CTP-543 in healthy subjects.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CTP-543 | Experimental | Drug: CTP-543 | On Day 1, participants will receive a single oral dose of CTP-543. Following a washout period on Days 2 and 3, participants will receive a single oral dose of rifampin on Day 4 through Day 15, with a single oral dose of CTP-543 being co-administered on Day 14. |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Clinical Pharmacology of Miami | Miami, Florida | United States |