Healthy ParticipantsPhase 1NCT06411730
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
A Phase 1 study testing BMS-986368 in people with Healthy Participants, run by Celgene at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986368
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 28 Oct 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be healthy male or non-pregnant and non-nursing female individuals.
- For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese).
- Participants must have a body mass index (BMI) of 18.0 kg/m2 to 33.0 kg/m2, inclusive.
- Participants must have normal renal function at screening.
Who cannot join
- Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder.
- Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator.
- Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia.
- Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening.
- Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.
- Conditions
- Healthy Participants
- Being tested
- BMS-986368
- Keywords
- Pharmacokinetics, Pharmacodynamics, BMS-986368, CC-97489, Healthy Volunteers, Elderly Volunteers, Japanese Volunteers, Multiple Ascending Dose, Healthy Participants, Elderly Participants, Japanese Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986368Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 1B | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 1C | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 2A | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 2B | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 2C | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 2D | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 3A | Experimental | Not described Receives: Drug: BMS-986368 |
| Cohort 3B | Experimental | Not described Receives: Drug: BMS-986368 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 44 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 44 days
Number of participants with vital sign (VS) abnormalities
Measured: Up to 21 days
Number of participants with physical examination abnormalities
Measured: Up to 21 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 21 days
Number of participants with clinical laboratory asssement abnormalities
Measured: Up to 21 days
Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 21 days
Secondary outcomes (9)
Area under the plasma concentration-time curve (AUC)
Measured: Up to 16 days
Maximum observed plasma concentration (Cmax)
Measured: Up to 16 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 16 days
Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
Measured: Up to 21 days
Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
Measured: Up to 21 days
Plasma concentrations of anandamide (AEA)
Measured: Up to 21 days
Percent change from baseline of anandamide (AEA)
Measured: Up to 21 days
Whole blood concentrations of 2-arachidonoylglycerol (2-AG)
Measured: Up to 21 days
Percent change from baseline of 2-arachidonoylglycerol (2-AG)
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start31 May 2024
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- 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
- NCT06411730
- Sponsor's protocol ID
- IM045-1009
- Status last verified
- Nov 2024
- First submitted
- 29 Apr 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
- ClinicalTrials.gov ID
- NCT06411730
- Acronym / sponsor ID
- IM045-1009
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Pharmacodynamics, BMS-986368, CC-97489, Healthy Volunteers, Elderly Volunteers, Japanese Volunteers, Multiple Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 31 May 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 13 May 2024 (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 evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: BMS-986368 |
| Cohort 1B | Experimental | Drug: BMS-986368 |
| Cohort 1C | Experimental | Drug: BMS-986368 |
| Cohort 2A | Experimental | Drug: BMS-986368 |
| Cohort 2B | Experimental | Drug: BMS-986368 |
| Cohort 2C | Experimental | Drug: BMS-986368 |
| Cohort 2D | Experimental | Drug: BMS-986368 |
| Cohort 3A | Experimental | Drug: BMS-986368 |
| Cohort 3B | Experimental | Drug: BMS-986368 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be healthy male or non-pregnant and non-nursing female individuals.
- For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese).
- Participants must have a body mass index (BMI) of 18.0 kg/m2 to 33.0 kg/m2, inclusive.
- Participants must have normal renal function at screening.
Key exclusion criteria (6 listed)
- Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder.
- Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator.
- Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia.
- Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening.
- Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity).
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-986368Specified dose on specified days | Drug | Cohort 1A, Cohort 1B, Cohort 1C, Cohort 2A, Cohort 2B, Cohort 2C, Cohort 2D, Cohort 3A, Cohort 3B |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 44 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 44 days
Number of participants with vital sign (VS) abnormalities
Time frame: Up to 21 days
Number of participants with physical examination abnormalities
Time frame: Up to 21 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 21 days
Number of participants with clinical laboratory asssement abnormalities
Time frame: Up to 21 days
Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 21 days
9 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 16 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 16 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 16 days
Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
Time frame: Up to 21 days
Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
Time frame: Up to 21 days
Plasma concentrations of anandamide (AEA)
Time frame: Up to 21 days
Percent change from baseline of anandamide (AEA)
Time frame: Up to 21 days
Whole blood concentrations of 2-arachidonoylglycerol (2-AG)
Time frame: Up to 21 days
Percent change from baseline of 2-arachidonoylglycerol (2-AG)
Time frame: Up to 21 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 12 Nov 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer 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
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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-986368 in people with Healthy Participants, run by Celgene 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 4 inclusion and 6 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 12 Nov 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?
Number of participants with adverse events (AEs) (time frame: Up to 44 days). The study lists 7 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 12 Nov 2024.