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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Fedratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051553

CA054-013

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 5 patient groups

Treatment 1A

Experimental group

Treatment:

Drug: Fedratinib

Treatment 1B

Experimental group

Treatment:

Drug: Fedratinib

Treatment 2A

Experimental group

Treatment:

Drug: Fedratinib

Treatment 2B

Experimental group

Treatment:

Drug: Fedratinib

Treatment 2C

Experimental group

Treatment:

Drug: Fedratinib