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BMS-986369, Part 1 dose escalation 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 336 hours after dose administration

Awards & highlights

Study Summary

This trialevaluates the safety and tolerability of a drug, and its drug levels, when taken as a single dose and with food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 336 hours after dose administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 336 hours after dose administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 336 hours after dose administration 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))

Maximum observed plasma concentration (Cmax)

Time of maximum observed plasma concentration (Tmax)

Secondary outcome measures

Effect of BMS-986369 on ECG parameters - Part 1

Number of participants with Adverse Events (AEs)

Number of participants with clinical laboratory abnormalities

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: BMS-986369, Part 1 dose escalationExperimental Treatment1 Intervention

Group II: BMS-986369 under fed conditions, Part 2 Food effectExperimental Treatment1 Intervention

Group III: BMS-986369 under fasted conditions, Part 2 Food effectExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986369

2022

Completed Phase 1

~80

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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

2,638 Previous Clinical Trials

4,128,446 Total Patients Enrolled

Frequently Asked Questions

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

Can I partake in the medical study?

"The current state of the trial requires potential subjects to be hale and hearty with ages within 18-55. It is now recruiting approximately 68 participants."

Answered by AI

Could you provide the aggregate population size of participants in this experiment?

"Indeed, the information accessible on clinicaltrials.gov suggests that this medical trial is actively recruiting patients as of today. It was initially posted on September 12th 2022 and has since been updated as recently as October 5th 2022. The study requires 68 participants from a single site to complete it's enrolment process."

Answered by AI

Does the age cutoff for this experiment extend beyond thirty years old?

"The age range for participant recruitment is between 18 and 55, as established by the study's eligibility criteria."

Answered by AI

Has the FDA granted clearance for administering BMS-986369 while fasting in Part 2 Food effect studies?

"BMS-986369 has received a safety rating of 1, which is in line with the lack of data associated with phase one clinical trials. This score reflects its efficacy and security under fasted conditions, Part 2 Food effect."

Answered by AI

Are there any remaining slots available for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour is looking for volunteers with the initial post date being September 12th 2022 and most recent update of October 5th 2022. 68 participants are needed at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

2022. "A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05350800.