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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05303220
• Other study ID #: IM014-036
• Secondary ID: 2015-004300-38
• Status: Completed
• Phase: Phase 1
• Start date: April 8, 2022
• Est. completion date: August 18, 2022

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Branebrutinib
Specified dose on specified days
• Placebo
Specified Dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to Day 14
Primary	Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))		Up to Day 14
Primary	AUC from time zero extrapolated to infinite time (AUC(INF))		Up to Day 14
Primary	Number of participants with adverse events (AEs)		Up to 30 days post last scheduled visit
Primary	Number of participants with vital sign abnormalities		Up to Day 14
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 14
Primary	Number of participants with physical examination abnormalities		Up to Day 14
Primary	Number of participants with clinical laboratory abnormalities		Up to Day 14
Secondary	Geometric mean ratio of Cmax		Up to Day 17
Secondary	Geometric mean ratio of AUC(0-T)		Up to Day 17
Secondary	Geometric mean ratio of AUC(INF)		Up to Day 17
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to Day 17
Secondary	Apparent total body clearance (CLT/F)		Up to Day 14
Secondary	Apparent volume of distribution (Vz/F)		Up to Day 14
Secondary	Number of participants with AEs		Up to 30 days post last scheduled visit
Secondary	Number of participants with vital sign abnormalities		Up to Day 14
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 14
Secondary	Number of participants with physical examination abnormalities		Up to Day 14
Secondary	Number of participants with clinical laboratory abnormalities		Up to Day 14

External Links

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