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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Branebrutinib

Specified dose on specified days

DRUG

Placebo

Specified Dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2022-08-18
Completion
2022-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303220 on ClinicalTrials.gov