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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

NCT ID: NCT05303220

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2022-08-18

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Treatment A

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 1 Treatment B

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 1 Treatment C

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 1 Treatment D

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 2 Treatment A

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 2 Treatment B

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 2 Treatment C

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 3 Treatment A

Group Type EXPERIMENTAL

Branebrutinib

Intervention Type DRUG

Specified dose on specified days

Part 3 Treatment B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Specified Dose on specified days

Interventions

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Branebrutinib

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified Dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986195

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female participants, of any race, as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations at screening or at check-in
* Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
* Participant is afebrile (febrile is defined as ≥ 38°C or ≥100.4°F), with systolic blood pressure ≥ 90 and ≤ 160 mm Hg, diastolic blood pressure ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at screening

Exclusion Criteria

* Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
* History of acute or chronic bacterial, fungal, or viral infection necessitating treatment or inpatient admission within the 3 months prior to screening, or active/symptomatic infection at the time of screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2015-004300-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM014-036

Identifier Type: -

Identifier Source: org_study_id

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