Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Concert Pharmaceuticals
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.
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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
Clareo Health | Open-Label Crossover Study Comparing CTP-543 to Jakafi®
