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Cardiac Myosin Activator

Caucasian Cohort - Dose 3 for Healthy Subjects

Phase 1

Recruiting

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 day 1 up to day 28

Awards & highlights

Study Summary

This trial is testing how safe and well-tolerated a drug is, and how it moves in the body, in healthy people of Japanese and Caucasian backgrounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (AEs)

Number of Participants with Clinical Laboratory Abnormalities

Number of Participants with Electrocardiogram (ECG) Abnormalities

+2 more

Secondary outcome measures

Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)]

Maximum Observed Plasma Concentration (Cmax)

Time of Maximum Observed Plasma Concentration (Tmax)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Japanese Cohort - Dose 3Experimental Treatment2 Interventions

Group II: Japanese Cohort - Dose 2Experimental Treatment2 Interventions

Group III: Japanese Cohort - Dose 1Experimental Treatment2 Interventions

Group IV: Caucasian Cohort - Dose 3Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Danicamtiv

2023

Completed Phase 1

~70

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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

4,128,482 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 this trial permit those who are of legal age to participate?

"This trial is seeking patients that are between 18 and 55 years old. There exist 54 clinical trials specifically for minors, while over 65s have access to 367 separate studies."

Answered by AI

Who is eligible for inclusion in this research endeavor?

"This trial is seeking 32 qualified individuals with healthy records, aged 18 to 55."

Answered by AI

Could you explain the potential risks of Japanese Cohort - Dose 1 for patients?

"With limited data available on both safety and efficacy, this Japanese Cohort - Dose 1 has a score of 1 when it comes to its relative safety."

Answered by AI

Are there any current openings to participate in the trial?

"At this time, clinicaltrials.gov reflects that the medical trial is not presently recruiting patients. The research was initially posted on March 31st 2023 and was last updated two days ago. Despite this, 810 other studies are actively looking for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

2023. "A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05806359.