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 | Completed Phase 1 FDA Drug

• 2 other identifiers: IM014-0362015-004300-38
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• 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

Study Arms (9)

Part 1 Treatment A

EXPERIMENTAL

Drug: Branebrutinib

Part 1 Treatment B

EXPERIMENTAL

Drug: Branebrutinib

Part 1 Treatment C

EXPERIMENTAL

Drug: Branebrutinib

Part 1 Treatment D

EXPERIMENTAL

Drug: Branebrutinib

Part 2 Treatment A

EXPERIMENTAL

Drug: Branebrutinib

Part 2 Treatment B

EXPERIMENTAL

Drug: Branebrutinib

Part 2 Treatment C

EXPERIMENTAL

Drug: Branebrutinib

Part 3 Treatment A

EXPERIMENTAL

Drug: Branebrutinib

Part 3 Treatment B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Branebrutinib DRUG

Specified dose on specified days

Also known as: BMS-986195

Part 1 Treatment A; Part 1 Treatment B; Part 1 Treatment C; Part 1 Treatment D; Part 2 Treatment A; Part 2 Treatment B; Part 2 Treatment C; Part 3 Treatment A

Placebo DRUG

Specified Dose on specified days

Part 3 Treatment B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Miami, Florida, 33136, United States

Location

Related Links

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

MeSH Terms

Interventions

branebrutinib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 8, 2022
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (1)