Healthy Adult VolunteersPhase 1NCT06034899
A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants
A Phase 1 study testing BMS-986196 in people with Healthy Adult Volunteers, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels 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 Adult Volunteers
- What is being tested?
- BMS-986196
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2023to 30 Nov 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 participants 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 assessments.
- Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and body weight ≥ 50 kg.
- Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).
Who cannot join
- Any significant acute or chronic medical illness in the assessment of the investigator.
- Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
- Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
- Note: Other protocol-defined inclusion/exclusion criteria apply.
About this study
Official title: A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult Participants
The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.
- Conditions
- Healthy Adult Volunteers
- Being tested
- BMS-986196
- Keywords
- BMS-986196, Healthy adult participants, Pharmacokinetics, Cross-over study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986196Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BMS-986196 Dose 1 (Treatment A) | Experimental | Not described Receives: Drug: BMS-986196 |
| Part 1: BMS-986196 Dose 1 (Treatment B) | Experimental | Not described Receives: Drug: BMS-986196 |
| Part 2: BMS-986196 Dose 2 (Treatment A) | Experimental | Not described Receives: Drug: BMS-986196 |
| Part 2: BMS-986196 Dose 2 (Treatment B) | Experimental | Not described Receives: Drug: BMS-986196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: Predose and post-dose up to Day 10
Maximum observed serum concentration (Cmax)
Measured: Predose and post-dose up to Day 10
Time of Cmax (Tmax)
Measured: Predose and post-dose up to Day 10
Secondary outcomes (7)
Number of participants with adverse events (AEs)
Measured: Up to Day 36
Number of participants with serious AEs (SAEs)
Measured: Up to Day 36
Number of participants with vital sign abnormalities
Measured: Up to Day 11
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 11
Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11
Measured: Baseline, Day 11
Number of participants with physical examination findings
Measured: Up to Day 11
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start22 Sep 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT06034899
- Sponsor's protocol ID
- IM038-1014
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 21 Sep 2023
- 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-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06034899
- Acronym / sponsor ID
- IM038-1014
- Conditions
- Healthy Adult Volunteers
- Keywords
- BMS-986196, Healthy adult participants, Pharmacokinetics, Cross-over study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 13 Sep 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 drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: BMS-986196 Dose 1 (Treatment A) | Experimental | Drug: BMS-986196 |
| Part 1: BMS-986196 Dose 1 (Treatment B) | Experimental | Drug: BMS-986196 |
| Part 2: BMS-986196 Dose 2 (Treatment A) | Experimental | Drug: BMS-986196 |
| Part 2: BMS-986196 Dose 2 (Treatment B) | Experimental | Drug: BMS-986196 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male participants 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 assessments.
- Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and body weight ≥ 50 kg.
- Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness in the assessment of the investigator.
- Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
- Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
- Note: 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-986196Specified dose on specified days | Drug | Part 1: BMS-986196 Dose 1 (Treatment A), Part 1: BMS-986196 Dose 1 (Treatment B), Part 2: BMS-986196 Dose 2 (Treatment A), Part 2: BMS-986196 Dose 2 (Treatment B) |
Primary outcome
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Predose and post-dose up to Day 10
Maximum observed serum concentration (Cmax)
Time frame: Predose and post-dose up to Day 10
Time of Cmax (Tmax)
Time frame: Predose and post-dose up to Day 10
7 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to Day 36
Number of participants with serious AEs (SAEs)
Time frame: Up to Day 36
Number of participants with vital sign abnormalities
Time frame: Up to Day 11
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 11
Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11
Time frame: Baseline, Day 11
Number of participants with physical examination findings
Time frame: Up to Day 11
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 11
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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-and-partners/clinical-trials-and-research/disclosure-commitment.html
Related trials for Healthy Adult Volunteers
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Enrolling by invitation
Brain Stimulation Paired With Structured Language Learning in Adults
Language Development, Learning
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986196 in people with Healthy Adult Volunteers, run by Bristol-Myers Squibb.
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: withdrawn, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) (time frame: Predose and post-dose up to Day 10). 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 21 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.