NCT02960945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

November 8, 2016

Last Update Submit

March 27, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (2)

  • 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

Study Arms (2)

CTP-543

EXPERIMENTAL

Tablet, single oral dose

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

Jakafi

ACTIVE COMPARATOR

Tablet, single oral dose

Drug: Jakafi 15Mg Tablet

Interventions

CTP-543, 16 mg (2 x 8 mg tablet)DRUG
CTP-543
Jakafi 15Mg TabletDRUG
Jakafi

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify 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 qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, United States

Location

MeSH Terms

Interventions

Tabletsruxolitinib

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 10, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)