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.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: Up to 30 days post participant's last study treatment
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Part 2
1 of 2
Part 1
1 of 2
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: Part 2 · No Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 50 · Male Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor