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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Branebrutinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Treatment A	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Experimental: Part 1 Treatment B	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Experimental: Part 1 Treatment C	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Experimental: Part 1 Treatment D	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Experimental: Part 2 Treatment A	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Experimental: Part 2 Treatment B	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Experimental: Part 2 Treatment C	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Experimental: Part 3 Treatment A	Drug: Branebrutinib; Specified dose on specified days; Other Names: BMS-986195
Placebo Comparator: Part 3 Treatment B	Drug: Placebo; Specified Dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to Day 14
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))	Up to Day 14
AUC from time zero extrapolated to infinite time (AUC(INF))	Up to Day 14
Number of participants with adverse events (AEs)	Up to 30 days post last scheduled visit
Number of participants with vital sign abnormalities	Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 14
Number of participants with physical examination abnormalities	Up to Day 14
Number of participants with clinical laboratory abnormalities	Up to Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with vital sign abnormalities	Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 14
Number of participants with physical examination abnormalities	Up to Day 14
Number of participants with clinical laboratory abnormalities	Up to Day 14
Geometric mean ratio of Cmax	Up to Day 17
Geometric mean ratio of AUC(0-T)	Up to Day 17
Geometric mean ratio of AUC(INF)	Up to Day 17
Time of maximum observed plasma concentration (Tmax)	Up to Day 17
Apparent total body clearance (CLT/F)	Up to Day 14
Apparent volume of distribution (Vz/F)	Up to Day 14
Number of participants with AEs	Up to 30 days post last scheduled visit

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Branebrutinib
• Other Study ID Numbers: IM014-036; 2015-004300-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No