Healthy VolunteersPhase 1NCT05303220
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 study testing Branebrutinib in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Branebrutinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 18 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Branebrutinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BranebrutinibDrug
Also called BMS-986195
Specified dose on specified days
PlaceboDrug
Specified Dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Treatment A | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 1 Treatment B | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 1 Treatment C | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 1 Treatment D | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 2 Treatment A | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 2 Treatment B | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 2 Treatment C | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 3 Treatment A | Experimental | Not described Receives: Drug: Branebrutinib |
| Part 3 Treatment B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 14
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 14
AUC from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 14
Number of participants with adverse events (AEs)
Measured: Up to 30 days post last scheduled visit
Number of participants with vital sign abnormalities
Measured: Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 14
Number of participants with physical examination abnormalities
Measured: Up to Day 14
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 14
Secondary outcomes (11)
Geometric mean ratio of Cmax
Measured: Up to Day 17
Geometric mean ratio of AUC(0-T)
Measured: Up to Day 17
Geometric mean ratio of AUC(INF)
Measured: Up to Day 17
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 17
Apparent total body clearance (CLT/F)
Measured: Up to Day 14
Apparent volume of distribution (Vz/F)
Measured: Up to Day 14
Number of participants with AEs
Measured: Up to 30 days post last scheduled visit
Number of participants with vital sign abnormalities
Measured: Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 14
Number of participants with physical examination abnormalities
Measured: Up to Day 14
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start8 Apr 2022
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303220
- Sponsor's protocol ID
- IM014-036
- Other IDs
- 2015-004300-38, 2015
- Status last verified
- Feb 2023
- First submitted
- 21 Mar 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05303220
- Acronym / sponsor ID
- IM014-036
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BranebrutinibAlso: BMS-986195Specified dose on specified days | Drug | 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 |
| PlaceboSpecified Dose on specified days | Drug | Part 3 Treatment B |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 14
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
AUC from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 14
Number of participants with adverse events (AEs)
Time frame: Up to 30 days post last scheduled visit
Number of participants with vital sign abnormalities
Time frame: Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 14
Number of participants with physical examination abnormalities
Time frame: Up to Day 14
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 14
11 secondary outcomes
Geometric mean ratio of Cmax
Time frame: Up to Day 17
Geometric mean ratio of AUC(0-T)
Time frame: Up to Day 17
Geometric mean ratio of AUC(INF)
Time frame: Up to Day 17
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 17
Apparent total body clearance (CLT/F)
Time frame: Up to Day 14
Apparent volume of distribution (Vz/F)
Time frame: Up to Day 14
Number of participants with AEs
Time frame: Up to 30 days post last scheduled visit
Number of participants with vital sign abnormalities
Time frame: Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 14
Number of participants with physical examination abnormalities
Time frame: Up to Day 14
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Branebrutinib in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to Day 14). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.