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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Branebrutinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05303220

IM014-036

2015-004300-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 9 patient groups, including a placebo group

Part 1 Treatment A

Experimental group

Treatment:

Drug: Branebrutinib

Part 1 Treatment B

Experimental group

Treatment:

Drug: Branebrutinib

Part 1 Treatment C

Experimental group

Treatment:

Drug: Branebrutinib

Part 1 Treatment D

Experimental group

Treatment:

Drug: Branebrutinib

Part 2 Treatment A

Experimental group

Treatment:

Drug: Branebrutinib

Part 2 Treatment B

Experimental group

Treatment:

Drug: Branebrutinib

Part 2 Treatment C

Experimental group

Treatment:

Drug: Branebrutinib

Part 3 Treatment A

Experimental group

Treatment:

Drug: Branebrutinib

Part 3 Treatment B

Placebo Comparator group

Treatment:

Drug: Placebo