drugset / Trial / NCT05303220

A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants

NCT05303220

Phase 1 Completed 56 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-04-08
Primary completion
2022-08-18
Completion
2022-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Branebrutinib Small molecule 9 mg Oral

Indications

No indication recorded.