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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CTP-543, 16 mg (2 x 8 mg tablet); Drug: Jakafi 15Mg Tablet

• Registration Number: NCT02960945
• Lead Sponsor: Concert Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Primary Completion: 2017-01
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CTP-543	CTP-543, 16 mg (2 x 8 mg tablet)	Tablet, single oral dose
Jakafi	Jakafi 15Mg Tablet	Tablet, single oral dose

Primary Outcome Measures

Name	Time	Method
Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions	24 hours

Secondary Outcome Measures

Name	Time	Method
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