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

Concert Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Jakafi 15Mg Tablet

Drug: CTP-543, 16 mg (2 x 8 mg tablet)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02960945

CP543.1002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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