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

An Open-Label Single-Dose Crossover Pharmacokinetic Study to Compare CTP-543 to Jakafi® in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02960945

Enrollment

Registered

2016-11-10

Start date

2016-11-30

Completion date

2017-03-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Detailed 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.

Interventions

DRUGCTP-543, 16 mg (2 x 8 mg tablet)

DRUGJakafi 15Mg Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions	24 hours

Secondary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 hours
Measurement of CTP-543 metabolites and exposure in urine under fasted conditions	24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026