Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects

Study Overview
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Brief Summary
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A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy subjects

Official Title
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A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects

Conditions
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Health Volunteers

Intervention / Treatment
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* Drug: CTP-543
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult, male or female, aged 18-60 inclusive Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks 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 (ICF), 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 or presence of alcohol or drug abuse within the past 2 years History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females at Screening visit or prior to the first dosing Abnormal liver function at Screening 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 for coronavirus infection (COVID-19) at Screening or check-in Positive drug or alcohol results at Screening or check-in Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) Vaccination with a live attenuated vaccine up to 6 weeks prior to dosing. Live vaccines include (but are not limited to) the measles, mumps, and rubella (MMR) vaccine; intranasal flu vaccine; and Zostavax for herpes zoster

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-543 and Fluconazole Treatment<br>On Day 1, each subject will receive a single oral dose of 12 mg CTP-543. Following a washout on Day 2, each subject will receive an oral dose of 200 mg fluconazole once daily on Days 3 through to Day 8. On Day 7, approximately 1 hour after the 200 mg dose of fluconazole, each subject will receive a single oral dose of 12 mg CTP-543. | Drug: CTP-543<br>* 12 mg on Day 1 and Day 7<br>Drug: Fluconazole<br>* 200 mg once daily on Days 3 through to Day 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum observed concentration | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose | 
| Tmax | Time to reach maximum observed concentration | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose | 
| λz | Terminal elimination rate constant | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose | 
| t1/2 | Apparent terminal half-life | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose | 
| AUC0-tlast | Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose | 
| AUC0-inf | Area under the concentration-time curve from time 0 extrapolated to infinity | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Safety and Tolerability following administration of CTP-543 | Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject | Continuous from screening (within 21 days prior to Day 1) through Discharge (approximately 7 days after last study drug administration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTP-543