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

NCT05051553 | Completed Phase 1 FDA Drug

• 1 other identifier: CA054-013
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Phase 1; Fedratinib

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (5)

Treatment 1A

EXPERIMENTAL

Drug: Fedratinib

Treatment 1B

EXPERIMENTAL

Drug: Fedratinib

Treatment 2A

EXPERIMENTAL

Drug: Fedratinib

Treatment 2B

EXPERIMENTAL

Drug: Fedratinib

Treatment 2C

EXPERIMENTAL

Drug: Fedratinib

Interventions

Fedratinib DRUG

Specified dose on specified days

Treatment 1A; Treatment 1B; Treatment 2A; Treatment 2B; Treatment 2C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Syneos Health Clinical Research Services, Llc

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Chen Y, Wyatt D, Attanasio M, Thomas M, Thomas M, He B, Nishii R, Liu L, Shan V, Xue Y, Carayannopoulos LN, Ogasawara K, Krishna G. Relative bioavailability of fedratinib through various alternative oral administration methods in healthy adults. Cancer Chemother Pharmacol. 2024 Apr;93(4):307-317. doi: 10.1007/s00280-023-04612-w. Epub 2023 Nov 13.

  PMID: 37955741 DERIVED

Related Links

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

MeSH Terms

Interventions

fedratinib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 21, 2021
• Study Start: September 21, 2021
• Primary Completion: December 23, 2021
• Study Completion: April 8, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

US (1)