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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05051553

Enrollment

Registered

2021-09-21

Start date

2021-09-21

Completion date

2022-04-08

Last updated

2022-06-27

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers, Phase 1, Fedratinib

Brief summary

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

Interventions

DRUGFedratinib

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

Measure	Time frame
Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)	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))	Up to 12 days
Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))	Up to 12 days

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026