A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants
NCT ID: NCT05615012
Last Updated: 2024-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
76 participants
INTERVENTIONAL
2022-11-11
2023-12-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
NCT05445440
Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients
NCT02456844
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir
NCT05236530
Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
NCT03131973
Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers
NCT02371603
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: Rosuvastatin + BMS-986322
BMS-986322
Specified dose on specified days
Rosuvastatin
Specified dose on specified days
Part 2: Metformin + BMS-986322 + Glucose
BMS-986322
Specified dose on specified days
Metformin
Specified dose on specified days
Glucose
Specified dose on specified days
Part 3: Methotrexate + BMS-986322 + Leucovorin
BMS-986322
Specified dose on specified days
Methotrexate
Specified dose on specified days
Leucovorin
Specified dose on specified days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-986322
Specified dose on specified days
Rosuvastatin
Specified dose on specified days
Metformin
Specified dose on specified days
Glucose
Specified dose on specified days
Methotrexate
Specified dose on specified days
Leucovorin
Specified dose on specified days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0001
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM032-039
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.