CompletedPhase 1/2

v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491

United States, France, Germany52 participantsStarted 2018-02-06

Plain-language summary

The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with stable heart failure.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Has stable chronic heart failure with reduced ejection fraction * Has adequate acoustic windows for echocardiography Key Exclusion Criteria: * Any significant structural cardiac abnormalities on Screening TTE * At Screening, symptomatic hypotension or hypertension or bradycardia. * Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, vasodilators \[e.g., nesiritide\], diuretics) or routinely scheduled ultrafiltration. * Presence of protocol specified laboratory abnormalities at Screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose to 30 days post last dose (Up to 2 months)

Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts

Timeframe: Baseline, day 1-16, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose

Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts

Timeframe: Baseline, Day 1-16, 2 hours pre-dose and at 7-, 24-, and 48-hours post final dose

Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts

Timeframe: Baseline and at 6-hours post-dose

Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts

Timeframe: Baseline and at 6-hours post-dose

Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts

Timeframe: Baseline and at 6-hours post-dose

Trial details

NCT IDNCT03447990

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-24

Results submitted2022-10-21

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose to 30 days post last dose (Up to 2 months)

Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts

Timeframe: Baseline, day 1-16, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose

Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts

Timeframe: Baseline, Day 1-16, 2 hours pre-dose and at 7-, 24-, and 48-hours post final dose

Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts

Timeframe: Baseline and at 6-hours post-dose

Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts

Timeframe: Baseline and at 6-hours post-dose

Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts

Timeframe: Baseline and at 6-hours post-dose