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Completed

NCT Number: NCT05303220

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

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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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Branebrutinib

Drug

Specified dose on specified days

Other names: BMS-986195

Placebo

Drug

Specified Dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 14

  2. Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to Day 14

  3. AUC from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 14

  4. Number of participants with adverse events (AEs)

    Time frame: Up to 30 days post last scheduled visit

  5. Number of participants with vital sign abnormalities

    Time frame: Up to Day 14

  6. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 14

  7. Number of participants with physical examination abnormalities

    Time frame: Up to Day 14

  8. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 14

Secondary outcomes

  1. Geometric mean ratio of Cmax

    Time frame: Up to Day 17

  2. Geometric mean ratio of AUC(0-T)

    Time frame: Up to Day 17

  3. Geometric mean ratio of AUC(INF)

    Time frame: Up to Day 17

  4. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 17

  5. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 14

  6. Apparent volume of distribution (Vz/F)

    Time frame: Up to Day 14

  7. Number of participants with AEs

    Time frame: Up to 30 days post last scheduled visit

  8. Number of participants with vital sign abnormalities

    Time frame: Up to Day 14

  9. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 14

  10. Number of participants with physical examination abnormalities

    Time frame: Up to Day 14

  11. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 14

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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