A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
- Registration Number
- NCT05051553
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment 1B Fedratinib - Treatment 2A Fedratinib - Treatment 2B Fedratinib - Treatment 2C Fedratinib - Treatment 1A Fedratinib -
- Primary Outcome Measures
Name Time Method Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF)) Up to 12 days 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
- Secondary Outcome Measures
Name Time Method Number of participants with clinically significant changes in electrocardiogram parameters Up to 66 days Incidence of serious adverse events (SAEs) Up to 66 days Incidence of clinically significant changes in vital signs: Body temperature 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 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: Clinical Chemistry tests Up to 66 days Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 66 days
Trial Locations
- Locations (1)
Syneos Health Clinical Research Services, Llc
🇺🇸Miami, Florida, United States