Healthy ParticipantsPhase 1NCT06144697
A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants
A Phase 1 study testing BMS-986465, Pegasys and Famotidine in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986465, Pegasys and Famotidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2024to 16 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female (i e, women not of childbearing potential) participants
- Body Mass Index (BMI) of 18 to 32 kg^m2 and total body weight ≥ 50 kg
- Parts A, B, and D: Participants without restriction on ethnicity
- Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)
Who cannot join
- Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
- Any major surgery within 3 months of study intervention administration
- Participation in another clinical trial concurrent with this study
- Note: Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 0001
Anaheim, California, 92801
Local Institution - 0003
Austin, Texas, 78744
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Prodrug BMS-986465 and Its Active Derivative, BMS-986464, in Healthy Participants Including Healthy Participants of Japanese Ethnicity and an Open-label Assessment of Food, Formulation, and pH Effects on the Relative Bioavailability of BMS-986465 and BMS-986464
The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.
- Conditions
- Healthy Participants
- Being tested
- BMS-986465, Placebo, Pegasys, Famotidine
- Keywords
- Pharmacokinetics, Pharmacodynamics, Healthy Participants, Healthy Japanese Participants, BMS-986465, SAD, MAD, Safety, Tolerability, Food Effects, Formulation, First-in-human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986465Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
PegasysDrug
Specified dose on specified days
FamotidineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo] | Experimental | Not described Receives: Drug: BMS-986465; Other: Placebo |
| Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] | Experimental | Not described Receives: Drug: BMS-986465; Other: Placebo; Drug: Pegasys |
| Part C: MAD in Japanese ethnicity [BMS-986465 or placebo] | Experimental | Not described Receives: Drug: BMS-986465; Other: Placebo |
| Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] | Experimental | Not described Receives: Drug: BMS-986465; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 28 days
Incidence of serious adverse events (SAEs)
Measured: Up to 28 days
Number of participants with vital sign abnormalities
Measured: Up to 28 days
Number of participants with physical examination abnormalities
Measured: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 28 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 28 days
Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 28 days
Secondary outcomes (5)
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 27
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 27
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Measured: Up to Day 27
Cerebrospinal fluid (CSF) concentrations
Measured: Up to Day 27
Ratios of CSF to plasma concentrations
Measured: Up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start29 Jan 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
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 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 267 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
- NCT06144697
- Sponsor's protocol ID
- CN009-1024
- Status last verified
- Feb 2025
- First submitted
- 17 Nov 2023
- Last updated
- 6 Feb 2025
- 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 Myer 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Prodrug BMS-986465 and Its Active Derivative, BMS-986464, in Healthy Participants Including Healthy Participants of Japanese Ethnicity and an Open-label Assessment of Food, Formulation, and pH Effects on the Relative Bioavailability of BMS-986465 and BMS-986464
- ClinicalTrials.gov ID
- NCT06144697
- Acronym / sponsor ID
- CN009-1024
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Pharmacodynamics, Healthy Participants, Healthy Japanese Participants, BMS-986465, SAD, MAD, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 22 Nov 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 evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo] | Experimental | Drug: BMS-986465, Other: Placebo |
| Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] | Experimental | Drug: BMS-986465, Other: Placebo, Drug: Pegasys |
| Part C: MAD in Japanese ethnicity [BMS-986465 or placebo] | Experimental | Drug: BMS-986465, Other: Placebo |
| Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] | Experimental | Drug: BMS-986465, Drug: Famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female (i e, women not of childbearing potential) participants
- Body Mass Index (BMI) of 18 to 32 kg^m2 and total body weight ≥ 50 kg
- Parts A, B, and D: Participants without restriction on ethnicity
- Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)
Key exclusion criteria (4 listed)
- Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
- Any major surgery within 3 months of study intervention administration
- Participation in another clinical trial concurrent with this study
- 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-986465Specified dose on specified days | Drug | Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo], Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys], Part C: MAD in Japanese ethnicity [BMS-986465 or placebo], Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] |
| PlaceboSpecified dose on specified days | Other | Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo], Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys], Part C: MAD in Japanese ethnicity [BMS-986465 or placebo] |
| PegasysSpecified dose on specified days | Drug | Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] |
| FamotidineSpecified dose on specified days | Drug | Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 28 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 28 days
Number of participants with vital sign abnormalities
Time frame: Up to 28 days
Number of participants with physical examination abnormalities
Time frame: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 28 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 28 days
Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 28 days
5 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 27
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 27
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 27
Cerebrospinal fluid (CSF) concentrations
Time frame: Up to Day 27
Ratios of CSF to plasma concentrations
Time frame: Up to 9 days
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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 Myer 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
2 sites 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-986465, Pegasys and Famotidine in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites 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 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: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
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?
Incidence of adverse events (AEs) (time frame: Up to 28 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 6 Feb 2025.