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Part 1: BMS-986278 + Sildenafil 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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after last dose

Awards & highlights

Study Summary

This trial tests the safety, side effects, and effectiveness of a new drug in healthy adults and Japanese participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after last dose 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 to the time of the last quantifiable concentration (AUC(0-T)) (Part 2)

Maximum observed plasma concentration (Cmax) (Part 2)

Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)

+1 more

Secondary outcome measures

AUC(0-T) (Part 1)

Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2)

Cmax (Part 1 and 2)

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: BMS-986278Experimental Treatment1 Intervention

Group II: Part 1: BMS-986278 + SildenafilExperimental Treatment2 Interventions

Group III: Part 2: PlaceboPlacebo Group1 Intervention

Group IV: Part 1: Placebo + SildenafilPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986278

2023

Completed Phase 2

~750

Sildenafil

2008

Completed Phase 4

~1690

Do I qualify?Apply below to find out

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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

4,128,439 Total Patients Enrolled

Frequently Asked Questions

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

Does the research include individuals aged 45 and over?

"For this experiment, only patients that are between 35 and 65 years old can be enrolled."

Answered by AI

What potential risks can be associated with taking Part 2: BMS-986278?

"Our assessment of the safety rating for BMS-986278 is a 1 as this is currently in Phase 1 trials, which means that data supporting both its efficacy and safety are scarce."

Answered by AI

How many participants are being investigated in this clinical experiment?

"Affirmative. Clinicaltrials.gov reports that this research endeavour, which was initially published on March 1st 2023, is actively recruiting patients. Sixty participants are required between two distinct health care facilities."

Answered by AI

Are applications being accepted for participation in this medical trial at the moment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial has been open for recruitment since March 1st, 2023 and was recently modified on February 9th, 2023. The enrollment objective is 60 participants over two medical locations."

Answered by AI

Can I join this research endeavor?

"This trial is recruiting 60 individuals between the ages of 35 and 65 who are considered healthy. Notably, for those in the Japanese cohort (Part 2), they must be first-generation citizens born in Japan with both parents of ethnic heritage from that country. Furthermore, participants should have a BMI ranging from 18 to 32 kg/m^2 while males need to weigh at least 50kg and females 45kg respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)

2023. "A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05684289.