Open-Label Crossover Study Comparing CTP-543 to Jakafi®

Study Overview
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Brief Summary
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This study will assess the metabolite and pharmacokinetic (PK) profile of a single dose of CTP-543 compared to a single dose of Jakafi® in healthy volunteers.

Detailed Description
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The crossover design will assess the safety, tolerability, PK and metabolite profiles of a single dose of CTP-543 compared to a single dose of Jakafi. Approximately 12 healthy volunteers will be enrolled in this open label study.

Official Title
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An Open-Label Single-Dose Crossover Pharmacokinetic Study to Compare CTP-543 to Jakafi® in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CTP-543, 16 mg (2 x 8 mg tablet)
* Drug: Jakafi 15Mg Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males and females between 18 and 50 years of age, inclusive Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive Exclusion Criteria: History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug History of herpes zoster Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug Liver function tests greater than the upper limit of normal Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody Urinalysis positive for protein or glucose A positive screen for alcohol, drugs of abuse, or tobacco use Donation of blood, plasma or other blood products prior to screening A positive tuberculosis test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-543<br>Tablet, single oral dose | Drug: CTP-543, 16 mg (2 x 8 mg tablet)<br> <br> |
| Active Comparator: Jakafi<br>Tablet, single oral dose | Drug: Jakafi 15Mg Tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 24 hours | 
| Measurement of CTP-543 metabolites and exposure in urine under fasted conditions |  | 24 hours |