Clinical trial NCT05051553: A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Phase 1
Fedratinib
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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/exclusion criteria apply

Primary outcomes:
measure: Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)
timeFrame: Up to 12 days
measure: 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))
timeFrame: Up to 12 days
measure: Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to 12 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 66 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 66 days
measure: Number of participants with clinically significant changes in electrocardiogram parameters
timeFrame: Up to 66 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 66 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 66 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 66 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 66 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 66 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 66 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 66 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Syneos Health Clinical Research Services, Llc
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: