Open-Label Crossover Study Comparing CTP-543 to Jakafi®
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 3/29/2017 |
Start Date: | November 2016 |
End Date: | March 2017 |
An Open-Label Single-Dose Crossover Pharmacokinetic Study to Compare CTP-543 to Jakafi® in Healthy Volunteers
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.
CTP-543 compared to a single dose of Jakafi® in healthy volunteers.
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.
single dose of CTP-543 compared to a single dose of Jakafi. Approximately 12 healthy
volunteers will be enrolled in this open label study.
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
We found this trial at
1
site
Click here to add this to my saved trials