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Part 2 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 30 days post participant's last study treatment
Awards & highlights

Study Summary

The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post participant's last study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post participant's last study treatment 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 the time of the last quantifiable concentration (AUC[0-T])
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
AUC(0-T)
AUC(INF)
Cmax
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment4 Interventions
Group II: Part 1Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulfasalazine
FDA approved
Leucovorin
FDA approved
BMS-986371
2022
Completed Phase 1
~30
Methotrexate
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,484 Total Patients Enrolled

Frequently Asked Questions

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

To what demographic does the enrollment criteria for this clinical trial apply?

"For admittance to this clinical trial, individuals need to possess healthy subject (hs) status and be between 18 and 50 years old. 32 participants are required in total."

Answered by AI

What purpose does this research endeavor aim to achieve?

"As stated by the research sponsor, Bristol-Myers Squibb, primary outcomes over a maximum of 22 days will be monitored to measure peak plasma concentration (Cmax). Secondary objectives such as the number of patients experiencing adverse events in Parts 1 and 2, Cmax in Part 2, and area under curve (AUC(0-T)) measurements in Part 2 are also being assessed."

Answered by AI

How many participants are being selected to join this trial?

"Affirmative. According to clinicaltrials.gov, recruitment for this experiment is in full swing; having first been posted on September 6th 2022 and most recently updated on October 10th of the same year. 32 volunteers are needed across one location for completion of the study."

Answered by AI

Does the eligibility of this research include individuals aged 65 or above?

"This particular clinical trial calls for participants between the ages of 18 and 50. For those under 18, there are approximately fifty trials they can enrol in while seniors over 65 have more than three hundred seventy-three options available to them."

Answered by AI

Is there capacity for additional participants in this research project?

"The clinical trial, posted on September 6th 2022, is recruiting patients. The details have been recently updated and are available as of October 10th 2022."

Answered by AI

What hazards do people face when engaging in Part 2?

"Unfortunately, the safety of Part 2 is not well supported by data yet and it thus received a score of 1 on our ranking scale. This assessment was made due to this being an initial stage trial with little evidence for its efficacy or protection from harm."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
2022. "A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445440.
~12 spots leftby Apr 2025
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