Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects

Study Overview
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Brief Summary
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This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.

Official Title
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A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inhibitor, Itraconazole, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CTP-543


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-543<br>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 itraconazole on Day 4 through Day 8, with a single oral dose of CTP-543 being co-administered on Day 7. | Drug: CTP-543<br>* Itraconazole in solution dosage form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | Area Under the Plasma Concentration-Time Profile | 48 hours | 
| AUC0-inf | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time | 48 hours | 
| Cmax | Maximum observed concentration of drug in plasma | 48 hours | 
| Tmax | Time to reach maximum observed concentration of drug in plasma | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) | 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 | Up to 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itraconazole, Drug-drug interaction, CTP-543