Overview
A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2021-12-29
2021-12-29
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers Squibb
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit: 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