Healthy VolunteersPhase 1NCT05932277
A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
A Phase 1 study testing BMS-986419, Caffeine and Bupropion 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 effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986419, Caffeine and Bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2023to 13 Sep 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1).
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.
Who cannot join
- Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
- Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention
- 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 Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in Healthy Participants
The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986419, Caffeine, Bupropion, Flurbiprofen, Omeprazole
- Keywords
- healthy, pharmacokinetics, BMS-986419
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986419Drug
Specified dose on specified days
CaffeineDrug
Specified dose on specified days
BupropionDrug
Specified dose on specified days
FlurbiprofenDrug
Specified dose on specified days
OmeprazoleDrug
Specified dose on specified days
MidazolamDrug
Specified dose on specified days
FexofenadineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cocktail Probe Substrates + BMS-986419 | Experimental | Not described Receives: Drug: BMS-986419; Drug: Caffeine; Drug: Bupropion; Drug: Flurbiprofen; Drug: Omeprazole; Drug: Midazolam; Drug: Fexofenadine |
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 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Measured: Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 25
Secondary outcomes (11)
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Measured: Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 25
Number of participants with Adverse Events (AEs)
Measured: Up to 28 days after last dose
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to 28 days after last dose
Number of participants with AEs leading to discontinuation
Measured: Up to 28 days after last dose
Number of participants with vital sign abnormalities
Measured: Up to Day 25
Number of participants with 12-lead ECG assessment abnormalities
Measured: Up to Day 25
Number of participants with physical examination abnormalities
Measured: Up to Day 25
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 25
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start29 Jun 2023
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT05932277
- Sponsor's protocol ID
- CN007-1000
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2023
- Last updated
- 30 Oct 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in Healthy Participants
- ClinicalTrials.gov ID
- NCT05932277
- Acronym / sponsor ID
- CN007-1000
- Conditions
- Healthy Volunteers
- Keywords
- healthy, pharmacokinetics, BMS-986419
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 6 Jul 2023 (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 effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cocktail Probe Substrates + BMS-986419 | Experimental | Drug: BMS-986419, Drug: Caffeine, Drug: Bupropion, Drug: Flurbiprofen, Drug: Omeprazole, Drug: Midazolam, Drug: Fexofenadine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1).
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.
Key exclusion criteria (3 listed)
- Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
- Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention
- 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 |
|---|---|---|
| BMS-986419Specified dose on specified days | Drug | Cocktail Probe Substrates + BMS-986419 |
| CaffeineSpecified dose on specified days | Drug | Cocktail Probe Substrates + BMS-986419 |
| BupropionSpecified dose on specified days | Drug | Cocktail Probe Substrates + BMS-986419 |
| FlurbiprofenSpecified dose on specified days | Drug | Cocktail Probe Substrates + BMS-986419 |
| OmeprazoleSpecified dose on specified days | Drug | Cocktail Probe Substrates + BMS-986419 |
| MidazolamSpecified dose on specified days | Drug | Cocktail Probe Substrates + BMS-986419 |
| FexofenadineSpecified dose on specified days | Drug | Cocktail Probe Substrates + BMS-986419 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 25
11 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 25
Number of participants with Adverse Events (AEs)
Time frame: Up to 28 days after last dose
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 28 days after last dose
Number of participants with AEs leading to discontinuation
Time frame: Up to 28 days after last dose
Number of participants with vital sign abnormalities
Time frame: Up to Day 25
Number of participants with 12-lead ECG assessment abnormalities
Time frame: Up to Day 25
Number of participants with physical examination abnormalities
Time frame: Up to Day 25
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 25
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 25
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 30 Oct 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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 BMS-986419, Caffeine and Bupropion 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 2 inclusion and 3 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 30 Oct 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. 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 25). The study lists 3 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 30 Oct 2023.