Trial · NCT03447990
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
NCT03447990, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2023-02-02
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491. Trials, record NCT03447990. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03447990
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
- NCT number
- NCT03447990
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Heart Failure With Reduced Ejection Fraction, Dilated Cardiomyopathy
- Interventions
- MYK-491, Placebo
- First posted
- 2018-02-27
- Last updated
- 2023-02-02
- Results first posted
- 2023-02-02
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose to 30 days post last dose (Up to 2 months) | Number of participants with any grade of treatment-emergent adverse events (TEAEs) and any grade of serious adverse events (SAEs). |
| Primary | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts | 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 ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to the corresponding period. |
| Primary | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts | Baseline, Day 1-16, 2 hours pre-dose and at 7-, 24-, and 48-hours post final dose | Number of participants with change from baseline in ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to first randomized dose. |
| Primary | Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts | Baseline and at 6-hours post-dose | Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period. |
| Primary | Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts | Baseline and at 6-hours post-dose | Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose |
| Primary | Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts | Baseline and at 6-hours post-dose | Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period. |
| Primary | Mean Change From Baseline in Vital Signs Part 2 - MAD Cohorts | Baseline and at 6-hours post-dose | Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose |
| Primary | Number of Participants With a Troponin I Increase - SAD Cohorts | Baseline, day 1-3, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose | Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16. |
| Primary | Number of Participants With a Troponin I Increase - MAD Cohorts | Baseline, pre-dose and 7hr post dose on treatment day 1, day 2, day 5 and pre-dose and at 7-, 24-, and 48-hours post final dose | Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16. |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | From first dose to 30 days post last dose (Up to 2 months) | Number of participants with clinically significant laboratory abnormalities. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose to 30 days post last dose (Up to 2 months) | All treated participants per regimen dosage | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts | Baseline, day 1-16, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose | All treated participants in SAD Cohorts per regimen dosage | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts | Baseline, Day 1-16, 2 hours pre-dose and at 7-, 24-, and 48-hours post final dose | All treated participants in MAD Cohorts per regimen dosage | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts | Baseline and at 6-hours post-dose | All treated participants in SAD Cohorts per regimen dosage | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts | Baseline and at 6-hours post-dose | Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts | Baseline and at 6-hours post-dose | All treated participants in SAD Cohorts per regimen dosage | Beats/min | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs Part 2 - MAD Cohorts | Baseline and at 6-hours post-dose | Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only | Beats/min | MEAN |
| PRIMARY | Number of Participants With a Troponin I Increase - SAD Cohorts | Baseline, day 1-3, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose | Pre-specified for data to be collected by combining all treated participants in SAD Cohorts per regimen only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Troponin I Increase - MAD Cohorts | Baseline, pre-dose and 7hr post dose on treatment day 1, day 2, day 5 and pre-dose and at 7-, 24-, and 48-hours post final dose | Pre-specified for data to be collected by combining all treated participants in MAD Cohorts per regimen only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities | From first dose to 30 days post last dose (Up to 2 months) | Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group209
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 1 Danicamtiv 175mg | TEAEs | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 1 Danicamtiv 350mg | TEAEs | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 1 Placebo | TEAEs | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 1 Danicamtiv 450mg | TEAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 1 Danicamtiv 525mg | TEAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 1 Danicamtiv 550mg | TEAEs | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 2 Danicamtiv 400mg | TEAEs | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 2 Danicamtiv 500mg | TEAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAD Cohort 2 Placebo | TEAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MAD Cohort 2 Danicamtiv 50mg | TEAEs | 7 | Participants |
1 to 10 of 209Source ClinicalTrials.gov
See all 209 results by groupParticipant flow49
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SAD Cohort 1 | 8 | |
| Overall Study | STARTED | SAD Cohort 2 | 4 | |
| Overall Study | STARTED | MAD Cohort 1 | 6 | |
| Overall Study | STARTED | MAD Cohort 2 | 9 | |
| Overall Study | STARTED | MAD Cohort 3 | 9 | |
| Overall Study | STARTED | MAD Cohort 4 | 6 | |
| Overall Study | STARTED | MAD Placebo | 10 | |
| Overall Study | Completed Blinded Treatment Period A | SAD Cohort 1 | 8 | |
| Overall Study | Completed Blinded Treatment Period A | SAD Cohort 2 | 4 | |
| Overall Study | Completed Blinded Treatment Period A | MAD Cohort 1 | 0 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 participant flowAdverse events900
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | SAD Cohort 1 Danicamtiv 175mg | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | SAD Cohort 1 Danicamtiv 350mg | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | SAD Cohort 1 Placebo | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | SAD Cohort 1 Danicamtiv Optional Period D | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | SAD Cohort 2 Danicamtiv 400mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | SAD Cohort 2 Danicamtiv 500mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | SAD Cohort 2 Placebo | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | MAD Cohort 1 Danicamtiv 75mg | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | MAD Cohort 1 Placebo | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | MAD Cohort 2 Danicamtiv 50mg | 0 | 9 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SAD Cohort 1 Danicamtiv 175mg | 0 | 8 |
| Total, all-cause mortality | SAD Cohort 1 Danicamtiv 350mg | 0 | 8 |
| Total, all-cause mortality | SAD Cohort 1 Placebo | 0 | 8 |
| Total, all-cause mortality | SAD Cohort 1 Danicamtiv Optional Period D | 0 | 6 |
| Total, all-cause mortality | SAD Cohort 2 Danicamtiv 400mg | 0 | 4 |
| Total, all-cause mortality | SAD Cohort 2 Danicamtiv 500mg | 0 | 4 |
| Total, all-cause mortality | SAD Cohort 2 Placebo | 0 | 4 |
| Total, all-cause mortality | MAD Cohort 1 Danicamtiv 75mg | 0 | 6 |
| Total, all-cause mortality | MAD Cohort 1 Placebo | 0 | 2 |
| Total, all-cause mortality | MAD Cohort 2 Danicamtiv 50mg | 0 | 9 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAD Cohorts vs MAD Cohorts: Number of Participants With Clinically Significant Physical Examinations Abnormalities | Trial comparisons |
| SAD Cohorts vs MAD Cohorts: Number of Participants With Clinically Significant Laboratory Abnormalities | Trial comparisons |
| MAD Cohorts Danicamtiv vs MAD Cohorts Placebo: Number of Participants With a Troponin I Increase - MAD Cohorts | Trial comparisons |
| SAD Cohorts Danicamtiv vs SAD Cohorts Placebo: Number of Participants With a Troponin I Increase - SAD Cohorts | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03447990
GET https://conductscience.org/api/trials/v1/NCT03447990/registered?page=2