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Monoclonal Antibodies

BMS-986322 + Rosuvastatin + Metformin + Methotrexate for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 51 days
Awards & highlights

Study Summary

This trial will study how drugs interact when taken together to see if they work better than when taken alone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 51 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 51 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
Apparent terminal phase half-life (T-HALF)
Apparent total body clearance (CLT/F)
Number of participants with adverse events (AEs)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: Methotrexate + BMS-986322 + LeucovorinExperimental Treatment3 Interventions
Group II: Part 2: Metformin + BMS-986322 + GlucoseExperimental Treatment3 Interventions
Group III: Part 1: Rosuvastatin + BMS-986322Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2013
Completed Phase 4
~3800
Leucovorin
2005
Completed Phase 4
~5730
BMS-986322
2022
Completed Phase 1
~330
Rosuvastatin
2019
Completed Phase 4
~3150
Metformin
2006
Completed Phase 4
~2430
Glucose
2017
Completed Phase 4
~850

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,636 Previous Clinical Trials
4,127,488 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative recruiting participants who are 50 years of age or older?

"To qualify for this study, the participant must be above 18 years of age but below 60."

Answered by AI

To what degree is the combination of Methotrexate + BMS-986322 + Leucovorin deemed safe for human use?

"Limited clinical data exists to support the safety and effectiveness of Methotrexate + BMS-986322 + Leucovorin, thus it was awarded a score of 1."

Answered by AI

How large is the cohort of participants in this research initiative?

"Affirmative. Clinicaltrials.gov specifies that the recruitment process for this clinical trial is ongoing, having been initially posted on November 11th 2022 and last updated September 7th 2023. The research team aims to enlist 76 participants at 1 medical facility."

Answered by AI

Does this investigation still have room for enrolment?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial is actively recruiting participants since its initial post on November 11th 2022 and last update of September 7th 2023. 76 individuals need to be recruited over one site for completion of the study."

Answered by AI

Are there any specific requirements for participating in this clinical experiment?

"This clinical trial seeks 76 individuals, aged between 18 and 60 who are judged to be in optimal health. To take part they must meet a number of conditions, including having a BMI from 18-30kg/m^2 and body weight over 50 kg for males or 45 kg for females. Additionally female participants may not donate oocytes during the experiment's duration or at least 5 days after their final dose of medication is administered."

Answered by AI
~31 spots leftby Apr 2025