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The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1A | Experimental |
| |
| Treatment 1B | Experimental |
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| Treatment 2A | Experimental |
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| Treatment 2B | Experimental |
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| Treatment 2C | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fedratinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health Clinical Research Services, Llc | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37955741 | Derived | 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. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| C528327 | fedratinib |
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| 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 |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 66 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 66 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 66 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 66 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 66 days |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |