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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Concert Pharmaceuticals

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