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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02960945

Run by

Concert Pharmaceuticals

People needed

12

Starts

2016-11-01

Expected to finish

2017-03-01

Last updated by the study team

2017-03-28

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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