Healthy VolunteersPhase 1NCT05963932
A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants
A Phase 1 study testing BMS-986419 DR Capsule and BMS-986419 IR Tablet 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 impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants. 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 DR Capsule and BMS-986419 IR Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 17 Oct 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, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
- Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, and body weight ≥ 50 kg.
- A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)
Who cannot join
- Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).
- History of Gilbert's syndrome.
- Women who are of childbearing potential and women who are breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Parallel-group, Single Dose Study to Assess the Relative Bioavailability of a New BMS-986419 Immediate-release Tablet Formulation Compared to a Reference Enteric Capsule (Delayed-release) Formulation, and to Assess the Effect of Food on the Pharmacokinetics of Immediate-release Tablet Formulation in Healthy Adult Participants
The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986419 DR Capsule, BMS-986419 IR Tablet
- Keywords
- BMS-986419, Healthy male of non-child bearing potential, Healthy women of non-child bearing potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986419 DR CapsuleDrug
Specified dose on specified days
BMS-986419 IR TabletDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: BMS-986419 DR Capsule - Fasted | Experimental | Not described Receives: Drug: BMS-986419 DR Capsule |
| Treatment B: BMS-986419 IR Tablet - Fasted | Experimental | Not described Receives: Drug: BMS-986419 IR Tablet |
| Treatment C: BMS-986419 IR Tablet - Fed | Experimental | Not described Receives: Drug: BMS-986419 IR Tablet |
| Treatment D: BMS-986419 Crushed IR Tablet - Fed | Experimental | Not described Receives: Drug: BMS-986419 IR Tablet |
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 15 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: Up to 15 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Measured: Up to 15 days
Secondary outcomes (8)
Number of participants with adverse events (AEs)
Measured: Up to 29 days
Number of participants with vital sign abnormalities
Measured: Up to 29 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 29 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 29 days
Number of participants with physical examination abnormalities
Measured: Up to 29 days
Time to attain maximum observed plasma concentration (Tmax)
Measured: Up to 15 days
Terminal half-life (T-Half)
Measured: Up to 15 days
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start8 Aug 2023
- Primary completion17 Oct 2023
- Study completion17 Oct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT05963932
- Sponsor's protocol ID
- CN007-1001
- Status last verified
- Jan 2024
- First submitted
- 20 Jul 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-andpartners/ clinical-trials-andresearch/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Parallel-group, Single Dose Study to Assess the Relative Bioavailability of a New BMS-986419 Immediate-release Tablet Formulation Compared to a Reference Enteric Capsule (Delayed-release) Formulation, and to Assess the Effect of Food on the Pharmacokinetics of Immediate-release Tablet Formulation in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05963932
- Acronym / sponsor ID
- CN007-1001
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986419, Healthy male of non-child bearing potential, Healthy women of non-child bearing potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 27 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 impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: BMS-986419 DR Capsule - Fasted | Experimental | Drug: BMS-986419 DR Capsule |
| Treatment B: BMS-986419 IR Tablet - Fasted | Experimental | Drug: BMS-986419 IR Tablet |
| Treatment C: BMS-986419 IR Tablet - Fed | Experimental | Drug: BMS-986419 IR Tablet |
| Treatment D: BMS-986419 Crushed IR Tablet - Fed | Experimental | Drug: BMS-986419 IR Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
- Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, and body weight ≥ 50 kg.
- A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).
- History of Gilbert's syndrome.
- Women who are of childbearing potential and women who are breastfeeding.
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-986419 DR CapsuleSpecified dose on specified days | Drug | Treatment A: BMS-986419 DR Capsule - Fasted |
| BMS-986419 IR TabletSpecified dose on specified days | Drug | Treatment B: BMS-986419 IR Tablet - Fasted, Treatment C: BMS-986419 IR Tablet - Fed, Treatment D: BMS-986419 Crushed IR Tablet - Fed |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 15 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Up to 15 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 15 days
8 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 29 days
Number of participants with vital sign abnormalities
Time frame: Up to 29 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 29 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 29 days
Number of participants with physical examination abnormalities
Time frame: Up to 29 days
Time to attain maximum observed plasma concentration (Tmax)
Time frame: Up to 15 days
Terminal half-life (T-Half)
Time frame: Up to 15 days
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
Time frame: Up to 15 days
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 23 Jan 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-andpartners/ clinical-trials-andresearch/disclosure-commitment.html
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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 DR Capsule and BMS-986419 IR Tablet 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 23 Jan 2024. 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 15 days). 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 23 Jan 2024.