Healthy ParticipantsPhase 1NCT05546151
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
A Phase 1 study testing BMS-986322 in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986322
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 7 Apr 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be of Japanese descent (both biological parents are ethnically Japanese).
- In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
- Women should be of non-childbearing potential.
Who cannot join
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
- Any major surgery within 90 days of study drug administration.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials Llc
Anaheim, California, 92801
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent
The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.
- Conditions
- Healthy Participants
- Being tested
- BMS-986322, Placebo for BMS-986322
- Keywords
- BMS-986322, Japanese descent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986322Drug
Specified dose on specified days
Placebo for BMS-986322Other
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort J1 | Experimental | Not described Receives: Drug: BMS-986322; Other: Placebo for BMS-986322 |
| Cohort J2 | Experimental | Not described Receives: Drug: BMS-986322; Other: Placebo for BMS-986322 |
| Cohort J3 | Experimental | Not described Receives: Drug: BMS-986322; Other: Placebo for BMS-986322 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with serious adverse events (SAEs)
Measured: Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation
Measured: Up to 7 weeks
Number of deaths
Measured: Up to 7 weeks
Number of participants with AEs
Measured: Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 7 weeks
Number of participants with vital sign abnormalities
Measured: Up to 7 weeks
Number of participants with physical examination abnormalities
Measured: Up to 7 weeks
Number of participants with clinical laboratory abnormalities
Measured: Up to 7 weeks
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax)
Measured: Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax)
Measured: Day 1 and Day 14
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start28 Sep 2022
- Primary completion7 Apr 2023
- Study completion7 Apr 2023
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT05546151
- Sponsor's protocol ID
- IM032-042
- Status last verified
- Jun 2023
- First submitted
- 15 Sep 2022
- Last updated
- 22 Jun 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/disclosurecommitment.html.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent
- ClinicalTrials.gov ID
- NCT05546151
- Acronym / sponsor ID
- IM032-042
- Conditions
- Healthy Participants
- Keywords
- BMS-986322, Japanese descent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 19 Sep 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 safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort J1 | Experimental | Drug: BMS-986322, Other: Placebo for BMS-986322 |
| Cohort J2 | Experimental | Drug: BMS-986322, Other: Placebo for BMS-986322 |
| Cohort J3 | Experimental | Drug: BMS-986322, Other: Placebo for BMS-986322 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant must be of Japanese descent (both biological parents are ethnically Japanese).
- In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
- Women should be of non-childbearing potential.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
- Any major surgery within 90 days of study drug administration.
- 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-986322Specified dose on specified days | Drug | Cohort J1, Cohort J2, Cohort J3 |
| Placebo for BMS-986322Specified dose on specified days | Other | Cohort J1, Cohort J2, Cohort J3 |
Primary outcome
Number of participants with serious adverse events (SAEs)
Time frame: Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation
Time frame: Up to 7 weeks
Number of deaths
Time frame: Up to 7 weeks
Number of participants with AEs
Time frame: Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 7 weeks
Number of participants with vital sign abnormalities
Time frame: Up to 7 weeks
Number of participants with physical examination abnormalities
Time frame: Up to 7 weeks
Number of participants with clinical laboratory abnormalities
Time frame: Up to 7 weeks
3 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax)
Time frame: Day 1 and Day 14
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Time frame: Day 1 and 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 22 Jun 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/disclosurecommitment.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-986322 in people with Healthy Participants, 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 22 Jun 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?
Number of participants with serious adverse events (SAEs) (time frame: Up to 7 weeks). 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 22 Jun 2023.