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Completed

NCT Number: NCT02960945

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Jakafi 15Mg Tablet

Drug

Primary outcomes

  1. Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions

    Time frame: 24 hours

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 24 hours

  2. Measurement of CTP-543 metabolites and exposure in urine under fasted conditions

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 10, 2016
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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