Local Institution - 0001
Miami, Florida, 33136, United States
NCT Number: NCT05303220
The purpose of this study is to assess the relative bioavailability of branebrutinib tablet formulation relative to the capsule formulation in order to identify doses that would provide exposures similar to the capsule formulation over the dose range that may be used in future clinical studies, evaluate the effect of food on the bioavailability of branebrutinib from a tablet formulation at a dose projected to provide similar pharmacokinetics (PK) as the 9 mg capsule formulation, and evaluate the safety and the PK of multiple oral dose of tablet formulation of branebrutinib in healthy participants.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Miami, Florida, 33136, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria apply
Specified dose on specified days
Other names: BMS-986195
Specified Dose on specified days
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to 30 days post last scheduled visit
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 17
Time frame: Up to Day 17
Time frame: Up to Day 17
Time frame: Up to Day 17
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to 30 days post last scheduled visit
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 14
Bristol-Myers Squibb
Industry
A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Branebrutinib in a Tablet Formulation Relative to Branebrutinib (RBA) in a Capsule Formulation Including the Effect of Food (Low-fat/Low-calorie and a High-fat/High-calorie) on the Bioavailability of Branebrutinib From a Tablet Formulation and a Double-blind Study to Evaluate the Safety and Pharmacokinetics of Branebrutinib From a Tablet Formulation in a Multiple-dose Arm in Healthy Participants
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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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