Status:
COMPLETED
Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04743414
Start Date
March 2 2021
End Date
April 5 2021
Last Update
April 8 2021
Active Locations (1)
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1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014