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Completed

NCT Number: NCT05051553

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Syneos Health Clinical Research Services, Llc

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fedratinib

Drug

Specified dose on specified days

Primary outcomes

  1. Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)

    Time frame: Up to 12 days

  2. 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))

    Time frame: Up to 12 days

  3. Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to 12 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 66 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 66 days

  3. Number of participants with clinically significant changes in electrocardiogram parameters

    Time frame: Up to 66 days

  4. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 66 days

  5. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 66 days

  6. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 66 days

  7. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 66 days

  8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: Up to 66 days

  9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: Up to 66 days

  10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: Up to 66 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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