Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

Study Overview
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Brief Summary
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This is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

Official Title
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A Phase 1 Open-Label, Two-Period, Two-Treatment, Crossover Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

Conditions
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Health Volunteers

Intervention / Treatment
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* Drug: CTP-543


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult, male or female, 18-60 years of age, inclusive Nonsmoker who has not used nicotine containing products for at least 3 months 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 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication Capable of giving informed consent and complying with study procedures. 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 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 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 (Day -1) Positive drug or alcohol results at screening Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) Participation in another clinical study within 30 days prior to, and 30 days after the first dosing

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 Fed:Fasted<br>Period 1: CTP-543 12 mg fed Period 2: CTP-543 12 mg fasted | Drug: CTP-543<br>* For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)<br>|
| Experimental: Sequence 2 Fasted:Fed<br>Period 1: CTP-543 12 mg fasted Period 2: CTP-543 12 mg fed | Drug: CTP-543<br>* For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax | Maximum observed concentration | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 
| Bioavailability and Pharmacokinetic Profile of CTP-543: Tmax | Time to reach maximum observed concentration | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 
| Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-Tlast) | Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 
| Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-inf) | Area under the concentration-time curve from time 0 extrapolated to infinity | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profile of major metabolites: Cmax | Maximum observed concentration | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 
| Pharmacokinetic Profile of major metabolites: Tmax | Time to reach maximum observed concentration | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 
| Pharmacokinetic Profile of major metabolites: AUC(0-Tlast) | Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 
| Pharmacokinetic Profile of major metabolites: AUC(0-inf) | Area under the concentration-time curve from time 0 extrapolated to infinity | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge | 
| 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 | Screening through 7 to 10 days after final dose administration | 

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