A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
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
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
- 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
- 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]
Eligibility Criteria
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:
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Allergy to or hypersensitive to any of the drugs or nutritional supplement used in the study
-
Prior history of Wernicke's Encephalopathy
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Thiamine deficiency
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Hypersensitivity to ondansetron
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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.- CA054-013