A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
NCT ID: NCT03402087
Last Updated: 2020-02-25
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
30 participants
INTERVENTIONAL
2018-01-08
2018-03-25
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 of BMS-986195 in Healthy Male Subjects
NCT03245515
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
NCT02705989
PoC in Rheumatoid Arthritis With Methotrexate
NCT00605735
Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis
NCT02504671
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
NCT02638948
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BMS-986165+Methotrexate+Leucovorin
Three treatments administered
Methotrexate
Specified dose on specified days
Leucovorin
Specified dose on specified days
BMS-986165
Specified dose on specified days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methotrexate
Specified dose on specified days
Leucovorin
Specified dose on specified days
BMS-986165
Specified dose on specified days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Normal renal function at screening
Exclusion Criteria
* Any contraindication indicated in the MTX package insert
* History or presence of chronic bacterial or viral infection
* History or presence of an autoimmune disorder
* Any significant acute or chronic medical illness
* Active TB requiring treatment or documented latent TB within the previous 3 years
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
18 Years
50 Years
MALE
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.
PRA Health Sciences
Groningen, , Netherlands
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 Patient Recruiting
Investigator Inquiry Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-004177-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.