Healthy VolunteersPhase 1NCT05051553
A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
A Phase 1 study testing Fedratinib in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fedratinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2021to 8 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Syneos Health Clinical Research Services, Llc
Miami, Florida, 33136
About this study
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
The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Fedratinib
- Keywords
- Healthy Volunteers, Phase 1, Fedratinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FedratinibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1A | Experimental | Not described Receives: Drug: Fedratinib |
| Treatment 1B | Experimental | Not described Receives: Drug: Fedratinib |
| Treatment 2A | Experimental | Not described Receives: Drug: Fedratinib |
| Treatment 2B | Experimental | Not described Receives: Drug: Fedratinib |
| Treatment 2C | Experimental | Not described Receives: Drug: Fedratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)
Measured: 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))
Measured: Up to 12 days
Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to 12 days
Secondary outcomes (10)
Incidence of Adverse Events (AEs)
Measured: Up to 66 days
Incidence of serious adverse events (SAEs)
Measured: Up to 66 days
Number of participants with clinically significant changes in electrocardiogram parameters
Measured: Up to 66 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 66 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 66 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 66 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 66 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start21 Sep 2021
- Primary completion23 Dec 2021
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051553
- Sponsor's protocol ID
- CA054-013
- Status last verified
- Jun 2022
- First submitted
- 16 Sep 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
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.
PubMed 37955741
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05051553
- Acronym / sponsor ID
- CA054-013
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Phase 1, Fedratinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FedratinibSpecified dose on specified days | Drug | Treatment 1A, Treatment 1B, Treatment 2A, Treatment 2B, Treatment 2C |
Primary outcome
Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)
Time frame: 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))
Time frame: Up to 12 days
Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 12 days
10 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 66 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 66 days
Number of participants with clinically significant changes in electrocardiogram parameters
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 66 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Derived from this study: PubMed 37955741Chen 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fedratinib in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax) (time frame: Up to 12 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.