Healthy ParticipantsPhase 1NCT05615012
A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants
A Phase 1 study testing BMS-986322, Rosuvastatin and Metformin in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants. 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, Rosuvastatin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2022to 13 Dec 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
- In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)^2 to 30.0 kg/m^2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening.
- A female participant is eligible to participate if she is a woman not of childbearing potential.
- Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention.
- For Parts 1 and 2 participants must be 18 to 60 years of age.
- For Part 3 participants must be 18 to 50 years of age.
Who cannot join
- Any significant acute or chronic medical illness.
- Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre [mL] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- Participant must not have a known or suspected immune-mediated disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status.
- Participant must not have any history or risk for tuberculosis (TB) in participants with current clinical, radiographic, or laboratory evidence of active TB.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State BMS-986322 on the Pharmacokinetics of Rosuvastatin (Part 1), the Pharmacokinetics and Pharmacodynamics of Metformin (Part 2) and the Pharmacokinetics of Methotrexate (Part 3) in Healthy Participants
The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986322, Rosuvastatin, Metformin, Glucose, Methotrexate
- Keywords
- BMS-986322, Rosuvastatin, Metformin, Methotrexate
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
RosuvastatinDrug
Specified dose on specified days
MetforminDrug
Specified dose on specified days
GlucoseDietary supplement
Specified dose on specified days
MethotrexateDrug
Specified dose on specified days
LeucovorinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Rosuvastatin + BMS-986322 | Experimental | Not described Receives: Drug: BMS-986322; Drug: Rosuvastatin |
| Part 2: Metformin + BMS-986322 + Glucose | Experimental | Not described Receives: Drug: BMS-986322; Drug: Metformin; Dietary Supplement: Glucose |
| Part 3: Methotrexate + BMS-986322 + Leucovorin | Experimental | Not described Receives: Drug: BMS-986322; Drug: Methotrexate; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 21 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Measured: Up to 21 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: Up to 21 days
Secondary outcomes (8)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 21 days
Apparent terminal phase half-life (T-HALF)
Measured: Up to 21 days
Apparent total body clearance (CLT/F)
Measured: Up to 21 days
Number of participants with adverse events (AEs)
Measured: Up to 51 days
Number of participants with vital sign abnormalities
Measured: Up to 51 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 51 days
Number of participants with physical examination abnormalities
Measured: Up to 51 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start11 Nov 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 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
- NCT05615012
- Sponsor's protocol ID
- IM032-039
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2022
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State BMS-986322 on the Pharmacokinetics of Rosuvastatin (Part 1), the Pharmacokinetics and Pharmacodynamics of Metformin (Part 2) and the Pharmacokinetics of Methotrexate (Part 3) in Healthy Participants
- ClinicalTrials.gov ID
- NCT05615012
- Acronym / sponsor ID
- IM032-039
- Conditions
- Healthy Participants
- Keywords
- BMS-986322, Rosuvastatin, Metformin, Methotrexate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 14 Nov 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 aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Rosuvastatin + BMS-986322 | Experimental | Drug: BMS-986322, Drug: Rosuvastatin |
| Part 2: Metformin + BMS-986322 + Glucose | Experimental | Drug: BMS-986322, Drug: Metformin, Dietary Supplement: Glucose |
| Part 3: Methotrexate + BMS-986322 + Leucovorin | Experimental | Drug: BMS-986322, Drug: Methotrexate, Drug: Leucovorin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)^2 to 30.0 kg/m^2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening.
- A female participant is eligible to participate if she is a woman not of childbearing potential.
- Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention.
- For Parts 1 and 2 participants must be 18 to 60 years of age.
Key exclusion criteria (6 listed)
- Any significant acute or chronic medical illness.
- Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre [mL] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- Participant must not have a known or suspected immune-mediated disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status.
- Participant must not have any history or risk for tuberculosis (TB) in participants with current clinical, radiographic, or laboratory evidence of active TB.
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 | Part 1: Rosuvastatin + BMS-986322, Part 2: Metformin + BMS-986322 + Glucose, Part 3: Methotrexate + BMS-986322 + Leucovorin |
| RosuvastatinSpecified dose on specified days | Drug | Part 1: Rosuvastatin + BMS-986322 |
| MetforminSpecified dose on specified days | Drug | Part 2: Metformin + BMS-986322 + Glucose |
| GlucoseSpecified dose on specified days | Dietary supplement | Part 2: Metformin + BMS-986322 + Glucose |
| MethotrexateSpecified dose on specified days | Drug | Part 3: Methotrexate + BMS-986322 + Leucovorin |
| LeucovorinSpecified dose on specified days | Drug | Part 3: Methotrexate + BMS-986322 + Leucovorin |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 21 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 21 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Up to 21 days
8 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 21 days
Apparent terminal phase half-life (T-HALF)
Time frame: Up to 21 days
Apparent total body clearance (CLT/F)
Time frame: Up to 21 days
Number of participants with adverse events (AEs)
Time frame: Up to 51 days
Number of participants with vital sign abnormalities
Time frame: Up to 51 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 51 days
Number of participants with physical examination abnormalities
Time frame: Up to 51 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 51 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 27 Mar 2024.
- BMS Clinical Trial InformationLink 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, Rosuvastatin and Metformin 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 6 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 27 Mar 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?
Maximum observed plasma concentration (Cmax) (time frame: Up to 21 days). 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 27 Mar 2024.