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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05051553
• Other study ID #: CA054-013
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 8, 2022
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Fedratinib
Specified dose on specified days

Locations

Country	Name	City	State
United States	Syneos Health Clinical Research Services, Llc	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)		Up to 12 days
Primary	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
Primary	Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))		Up to 12 days
Secondary	Incidence of Adverse Events (AEs)		Up to 66 days
Secondary	Incidence of serious adverse events (SAEs)		Up to 66 days
Secondary	Number of participants with clinically significant changes in electrocardiogram parameters		Up to 66 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 66 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 66 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 66 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 66 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 66 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 66 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 66 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls