A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants

June 22, 2022 updated by: Bristol-Myers Squibb

A Phase 1, Open-label, Single-center, 2-part Crossover Study to Evaluate the Relative Bioavailability of Fedratinib When Administered as Contents of Capsules Dispersed in a Nutritional Supplement Orally or Via Nasogastric Tube, or Administered Orally as Divided Doses of Intact Capsules With a Nutritional Supplement in Healthy Adult Subjects

The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Syneos Health Clinical Research Services, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

  • Body Mass Index (BMI) of 18.0 to 33.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
  • Healthy based on medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) at screening and check-in

Exclusion Criteria:

  • Allergy to or hypersensitive to any of the drugs or nutritional supplement used in the study
  • Prior history of Wernicke's Encephalopathy
  • Thiamine deficiency
  • Hypersensitivity to ondansetron
  • Has any medical condition, medical history, or use of concomitant medication that is contraindicated in the applicable drug labeling
  • Has history, deviated nasal septum, and/or obstructed airway, bleeding disorders, or other inabilities for insertion of nasogastric (NG) tube (Part 2 only)

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment 1A
Drug: Fedratinib
Specified dose on specified days
EXPERIMENTAL: Treatment 1B
Drug: Fedratinib
Specified dose on specified days
EXPERIMENTAL: Treatment 2A
Drug: Fedratinib
Specified dose on specified days
EXPERIMENTAL: Treatment 2B
Drug: Fedratinib
Specified dose on specified days
EXPERIMENTAL: Treatment 2C
Drug: Fedratinib
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)
Time Frame: Up to 12 days
Up to 12 days
Fedratinib Pharmacokinetics: Estimation of area under the curve (AUC) calculated from time zero to t, where t is the timepoint of the last quantifiable concentration (AUC(0-T))
Time Frame: Up to 12 days
Up to 12 days
Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Up to 12 days
Up to 12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 66 days
Up to 66 days
Incidence of serious adverse events (SAEs)
Time Frame: Up to 66 days
Up to 66 days
Number of participants with clinically significant changes in electrocardiogram parameters
Time Frame: Up to 66 days
Up to 66 days
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame: Up to 66 days
Up to 66 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to 66 days
Up to 66 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame: Up to 66 days
Up to 66 days
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame: Up to 66 days
Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 66 days
Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame: Up to 66 days
Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame: Up to 66 days
Up to 66 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2021

Primary Completion (ACTUAL)

December 23, 2021

Study Completion (ACTUAL)

April 8, 2022

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (ACTUAL)

September 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CA054-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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