Healthy VolunteersPhase 1NCT06877702
A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants
A Phase 1 study testing BMS-986460 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 safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986460
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 17 Dec 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.
- Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.
- Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.
Who cannot join
- Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.
- Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
- Participants with history of anaphylactic reactions are excluded.
- Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.
- Participants with history of Gilbert's syndrome are excluded.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)
The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986460
- Keywords
- BMS-986460, bioavailability, healthy adult male, crossover, SAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986460Drug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Sequence 1 | Experimental | Not described Receives: Drug: BMS-986460 |
| Part 1: Sequence 2 | Experimental | Not described Receives: Drug: BMS-986460 |
| Part 1: Sequence 3 | Experimental | Not described Receives: Drug: BMS-986460 |
| Part 2: Treatment A | Experimental | Not described Receives: Drug: BMS-986460 |
| Part 2: Treatment B | Experimental | Not described Receives: Drug: BMS-986460 |
| Part 2: Optional Treatment C | Experimental | Not described Receives: Drug: BMS-986460 |
| Part 2: Optional Treatment D | Experimental | Not described Receives: Drug: BMS-986460 |
| Part 2: Optional Treatment E | Experimental | Not described Receives: Drug: BMS-986460 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Adverse Events (AEs)
Measured: Up to approximately Day 43
Part 1: Number of Participants With Serious AEs (SAEs)
Measured: Up to approximately Day 43
Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings
Measured: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
Measured: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
Measured: Up to approximately Day 21
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460
Measured: Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460
Measured: Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460
Measured: Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460
Measured: Up to approximately Day 21
Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax
Measured: Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)
Measured: Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)
Measured: Up to approximately Day 21
Part 2: Number of Participants With AEs
Measured: Up to approximately Day 29
Part 2: Number of Participants With SAEs
Measured: Up to approximately Day 29
Part 2: Number of Participants With Clinically Significant PE Findings
Measured: Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities
Measured: Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings
Measured: Up to approximately Day 7
Part 2: Cmax of BMS-986460
Measured: Up to approximately Day 7
Part 2: Tmax of BMS-986460
Measured: Up to approximately Day 7
Part 2: AUC [0-T] of BMS-986460
Measured: Up to approximately Day 7
Part 2: AUC(INF) of BMS-986460
Measured: Up to approximately Day 7
Secondary outcomes (3)
Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax
Measured: Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)
Measured: Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(INF)
Measured: Up to approximately Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start19 Mar 2025
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 85 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
- NCT06877702
- Sponsor's protocol ID
- CA125-1018
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)
- ClinicalTrials.gov ID
- NCT06877702
- Acronym / sponsor ID
- CA125-1018
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986460, bioavailability, healthy adult male, crossover, SAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 14 Mar 2025 (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, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: Sequence 1 | Experimental | Drug: BMS-986460 |
| Part 1: Sequence 2 | Experimental | Drug: BMS-986460 |
| Part 1: Sequence 3 | Experimental | Drug: BMS-986460 |
| Part 2: Treatment A | Experimental | Drug: BMS-986460 |
| Part 2: Treatment B | Experimental | Drug: BMS-986460 |
| Part 2: Optional Treatment C | Experimental | Drug: BMS-986460 |
| Part 2: Optional Treatment D | Experimental | Drug: BMS-986460 |
| Part 2: Optional Treatment E | Experimental | Drug: BMS-986460 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.
- Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.
- Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.
Key exclusion criteria (6 listed)
- Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.
- Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
- Participants with history of anaphylactic reactions are excluded.
- Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.
- Participants with history of Gilbert's syndrome are excluded.
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-986460Specified dose on specified days. | Drug | Part 1: Sequence 1, Part 1: Sequence 2, Part 1: Sequence 3, Part 2: Optional Treatment C, Part 2: Optional Treatment D, Part 2: Optional Treatment E, Part 2: Treatment A, Part 2: Treatment B |
Primary outcome
Part 1: Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately Day 43
Part 1: Number of Participants With Serious AEs (SAEs)
Time frame: Up to approximately Day 43
Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings
Time frame: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
Time frame: Up to approximately Day 21
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460
Time frame: Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460
Time frame: Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460
Time frame: Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460
Time frame: Up to approximately Day 21
Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax
Time frame: Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)
Time frame: Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)
Time frame: Up to approximately Day 21
Part 2: Number of Participants With AEs
Time frame: Up to approximately Day 29
Part 2: Number of Participants With SAEs
Time frame: Up to approximately Day 29
Part 2: Number of Participants With Clinically Significant PE Findings
Time frame: Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings
Time frame: Up to approximately Day 7
Part 2: Cmax of BMS-986460
Time frame: Up to approximately Day 7
Part 2: Tmax of BMS-986460
Time frame: Up to approximately Day 7
Part 2: AUC [0-T] of BMS-986460
Time frame: Up to approximately Day 7
Part 2: AUC(INF) of BMS-986460
Time frame: Up to approximately Day 7
3 secondary outcomes
Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax
Time frame: Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)
Time frame: Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(INF)
Time frame: Up to approximately Day 7
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 20 Jan 2026.
- 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-986460 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 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 20 Jan 2026. 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?
Part 1: Number of Participants With Adverse Events (AEs) (time frame: Up to approximately Day 43). The study lists 23 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 20 Jan 2026.