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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02960945
Recruitment Status : Completed
First Posted : November 10, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CTP-543, 16 mg (2 x 8 mg tablet) Drug: Jakafi 15Mg Tablet Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label Single-Dose Crossover Pharmacokinetic Study to Compare CTP-543 to Jakafi® in Healthy Volunteers
Study Start Date : November 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CTP-543
Tablet, single oral dose
 Drug: CTP-543, 16 mg (2 x 8 mg tablet)
Active Comparator: Jakafi
Tablet, single oral dose
 Drug: Jakafi 15Mg Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 hours ]
  2. Measurement of CTP-543 metabolites and exposure in urine under fasted conditions [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960945


Locations
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United States, Arizona
Phoenix, Arizona, United States
Sponsors and Collaborators
Concert Pharmaceuticals
More Information
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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02960945    
Other Study ID Numbers: CP543.1002
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No