Open-Label Crossover Study Comparing CTP-543 to Jakafi®
NCT ID: NCT02960945
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2016-11-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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CTP-543
Tablet, single oral dose
CTP-543, 16 mg (2 x 8 mg tablet)
Jakafi
Tablet, single oral dose
Jakafi 15Mg Tablet
Interventions
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CTP-543, 16 mg (2 x 8 mg tablet)
Jakafi 15Mg Tablet
Eligibility Criteria
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Inclusion Criteria
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive
Exclusion Criteria
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Concert Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Countries
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Other Identifiers
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CP543.1002
Identifier Type: -
Identifier Source: org_study_id
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