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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT05051553
Collaborator
(none)
58
1
5
6.5
8.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 21, 2021
Actual Primary Completion Date :
Dec 23, 2021
Actual Study Completion Date :
Apr 8, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax) [Up to 12 days]

  2. 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)) [Up to 12 days]

  3. Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF)) [Up to 12 days]

Secondary Outcome Measures

  1. Incidence of Adverse Events (AEs) [Up to 66 days]

  2. Incidence of serious adverse events (SAEs) [Up to 66 days]

  3. Number of participants with clinically significant changes in electrocardiogram parameters [Up to 66 days]

  4. Incidence of clinically significant changes in vital signs: Body temperature [Up to 66 days]

  5. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 66 days]

  6. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 66 days]

  7. Incidence of clinically significant changes in vital signs: Heart rate [Up to 66 days]

  8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 66 days]

  9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 66 days]

  10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 66 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Syneos Health Clinical Research Services, Llc Miami Florida United States 33136

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT05051553
Other Study ID Numbers:
  • CA054-013
First Posted:
Sep 21, 2021
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bristol-Myers Squibb

Study Results

No Results Posted as of Jun 27, 2022