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

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

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Fedratinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1A<br> | Drug: Fedratinib<br>* Specified dose on specified days<br>|
| Experimental: Treatment 1B<br> | Drug: Fedratinib<br>* Specified dose on specified days<br>|
| Experimental: Treatment 2A<br> | Drug: Fedratinib<br>* Specified dose on specified days<br>|
| Experimental: Treatment 2B<br> | Drug: Fedratinib<br>* Specified dose on specified days<br>|
| Experimental: Treatment 2C<br> | Drug: Fedratinib<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | 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 | 
| 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 clinically significant changes in vital signs: Heart rate |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Phase 1, Fedratinib