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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1/SAD and Part 2/MAD - drug | Other | Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo |
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| Part 1/SAD and Part 2/MAD - placebo | Other | Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYK-491 | Drug | Single Ascending Dose and Multiple Ascending Dose of MYK-491 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Number of participants with any grade of treatment-emergent adverse events (TEAEs) and any grade of serious adverse events (SAEs). | 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 | 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. | 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 | 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. | 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 | 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. | Baseline and at 6-hours post-dose |
| Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts | 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 | Baseline and at 6-hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Danicamtiv Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States | ||
| Prism Reseach |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAD Cohort 1 | Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 175mg and Danicamtiv 350mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days. Some participants received a fourth single dose of Danicamtiv ranging between 350mg-550mg in the optional open-label period D |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2019 |
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This is a a two part study. The first part is a randomized, crossover, double-blind, placebo-controlled, two cohort, sequential ascending single dose study. All patients will receive placebo and active doses of MYK-491.
The second part is a randomized, parallel, double-blind, placebo-controlled, sequential ascending multiple dose study. All patients will receive placebo and/or active doses of MYK-491.
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| Placebo | Drug | Single Ascending Dose and Multiple Ascending Dose of placebo |
|
| Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts |
Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period. |
| Baseline and at 6-hours post-dose |
| Mean Change From Baseline in Vital Signs Part 2 - MAD Cohorts | Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose | Baseline and at 6-hours post-dose |
| Number of Participants With a Troponin I Increase - SAD Cohorts | 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. | 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 I Increase - MAD Cohorts | 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. | 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 Clinically Significant Laboratory Abnormalities | 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 Physical Examinations Abnormalities | Number of participants with clinically significant physical examinations abnormalities. | From first dose to 30 days post last dose (Up to 2 months) |
| Danicamtiv Time of Maximum Observed Plasma Concentration (Tmax) |
Time of maximum observed plasma concentration (Tmax) for Danicamtiv. |
| 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
| Area Under the Plasma Concentration-Time Curve (AUC) | Area under the plasma concentration-time curve (AUC) for Danicamtiv including the following time points: (AUC(0-12))=from time 0 to 12 hours; (AUC(0-24))=from time 0 to 24 hours; (AUC(0-48))=from time 0 to 48 hours; (AUClast)=from time 0 up to the last measurable concentration; (AUC(0-∞))=from time 0 to infinity. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
| Apparent First-order Terminal Elimination Half-life (t1/2) | Apparent first-order terminal elimination half-life (t1/2). | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
| Danicamtiv Accumulation Ratio for Maximum Observed Plasma Concentration AR(Cmax) - MAD Cohorts | Accumulation ratio for maximum observed plasma concentration AR(Cmax) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
| Accumulation Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours AR(AUC(0-12)) - MAD Cohorts | Accumulation ratio for area under the plasma concentration-time curve from time 0 to 12 hours AR(AUC(0-12)) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
| Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 1 - SAD Cohorts | Mean change from baseline in TTE parameter systolic ejection time (SET) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive | Baseline, predose and at 3, 6, 9, and 24 hours post dose |
| Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 2 - SAD Cohorts | Mean change from baseline in TTE parameter left ventricular stroke volume (LVSV) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive | Baseline, predose and at 3, 6, 9, and 24 hours post dose |
| Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - SAD Cohorts | Mean change from baseline in TTE parameter left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive | Baseline, predose and at 3, 6, 9, and 24 hours post dose |
| Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 1 - MAD Cohorts | Mean change from baseline in TTE parameter systolic ejection time (SET) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive | Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11 |
| Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 2 - MAD Cohorts | Mean change from baseline in TTE parameter left ventricular stroke volume (LVSV) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive | Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11 |
| Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - MAD Cohorts | Mean change from baseline in TTE parameter left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive | Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11 |
| Saint Paul |
| Minnesota |
| 55102 |
| United States |
| St. Louis Heart and Vascular Cardiology | St Louis | Missouri | 63136 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania Heart and Vascular Center | Philadelphia | Pennsylvania | 19104 | United States |
| Tennessee Center for Clinical Trials | Tullahoma | Tennessee | 37388 | United States |
| Hopital Europeen Georges-Pompidou | Paris | 75015 | France |
| Charite Research Organization | Berlin | 10117 | Germany |
| Groningen UMC | Groningen | 9713 GZ | Netherlands |
| D&A Research | Sneek | 8601 | Netherlands |
| Wojewodzki Szpital Specjalistyczny Im M Kopernika | Lodz | 93-513 | Poland |
| Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Kardiologiczny z Pododdzialem Intensywnego Nadzoru Kardiologicznego i Pododdzialem Leczenia Zaburzen Rytmu Serca | Wroclaw | 51-124 | Poland |
| Karolinska University Hospital | Stockholm | 17164 | Sweden |
| Queen Elizabeth University Hospital | Glasgow | Scotland | G51 4TF | United Kingdom |
| FG001 |
| SAD Cohort 2 |
Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 400mg and Danicamtiv 500mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days |
| FG002 | MAD Cohort 1 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (fasting) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| FG003 | MAD Cohort 2 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| FG004 | MAD Cohort 3 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| FG005 | MAD Cohort 4 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| FG006 | MAD Placebo | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
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| Completed Blinded Treatment Period A | Blinded treatment period A planned in SAD Cohort 1 and 2 |
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| Completed Blinded Treatment Period B | Blinded treatment period B planned in SAD Cohort 1 and 2 |
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| Completed Blinded Treatment Period C | Blinded treatment period C planned in SAD Cohort 1 and 2 |
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| Completed Optional Open-Label Treatment Period D | Optional open-label treatment period D planned in SAD Cohort 1 |
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| COMPLETED | Completed = completed treatment |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SAD Cohort 1 | Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 175mg and Danicamtiv 350mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days. Some participants received a fourth single dose of Danicamtiv ranging between 350mg-550mg in the optional open-label period D |
| BG001 | SAD Cohort 2 | Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 400mg and Danicamtiv 500mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days |
| BG002 | MAD Cohort 1 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (fasting) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| BG003 | MAD Cohort 2 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| BG004 | MAD Cohort 3 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| BG005 | MAD Cohort 4 | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| BG006 | MAD Placebo | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Number of participants with any grade of treatment-emergent adverse events (TEAEs) and any grade of serious adverse events (SAEs). | All treated participants per regimen dosage | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 2 months) |
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| Primary | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts | 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. | All treated participants in SAD Cohorts per regimen dosage | Posted | Count of Participants | Participants | Baseline, day 1-16, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose |
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| Primary | Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts | 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. | All treated participants in MAD Cohorts per regimen dosage | Posted | Count of Participants | Participants | Baseline, Day 1-16, 2 hours pre-dose and at 7-, 24-, and 48-hours post final dose |
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| Primary | Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts | 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. | All treated participants in SAD Cohorts per regimen dosage | Posted | Mean | Standard Deviation | mmHg | Baseline and at 6-hours post-dose |
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| Primary | Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts | 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 | Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only | Posted | Mean | Standard Deviation | mmHg | Baseline and at 6-hours post-dose |
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| Primary | Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts | Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period. | All treated participants in SAD Cohorts per regimen dosage | Posted | Mean | Standard Deviation | Beats/min | Baseline and at 6-hours post-dose |
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| Primary | Mean Change From Baseline in Vital Signs Part 2 - MAD Cohorts | Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose | Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only | Posted | Mean | Standard Deviation | Beats/min | Baseline and at 6-hours post-dose |
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| Primary | Number of Participants With a Troponin I Increase - SAD Cohorts | 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. | Pre-specified for data to be collected by combining all treated participants in SAD Cohorts per regimen only | Posted | Count of Participants | Participants | Baseline, day 1-3, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose |
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| Primary | Number of Participants With a Troponin I Increase - MAD Cohorts | 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. | Pre-specified for data to be collected by combining all treated participants in MAD Cohorts per regimen only | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | Number of participants with clinically significant laboratory abnormalities. | Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 2 months) |
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| Primary | Number of Participants With Clinically Significant Physical Examinations Abnormalities | Number of participants with clinically significant physical examinations abnormalities. | Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 2 months) |
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| Secondary | Danicamtiv Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants that received Danicamtiv with plasma concertation data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
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| Secondary | Danicamtiv Time of Maximum Observed Plasma Concentration (Tmax) | Time of maximum observed plasma concentration (Tmax) for Danicamtiv. | All participants that received Danicamtiv with plasma concertation data | Posted | Median | Full Range | hours | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
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| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) | Area under the plasma concentration-time curve (AUC) for Danicamtiv including the following time points: (AUC(0-12))=from time 0 to 12 hours; (AUC(0-24))=from time 0 to 24 hours; (AUC(0-48))=from time 0 to 48 hours; (AUClast)=from time 0 up to the last measurable concentration; (AUC(0-∞))=from time 0 to infinity. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants that received Danicamtiv with plasma concertation data | Posted | Geometric Mean | Geometric Coefficient of Variation | hr x ng/mL | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
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| Secondary | Apparent First-order Terminal Elimination Half-life (t1/2) | Apparent first-order terminal elimination half-life (t1/2). | All participants that received Danicamtiv with plasma concertation data | Posted | Mean | Standard Deviation | hours | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
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| Secondary | Danicamtiv Accumulation Ratio for Maximum Observed Plasma Concentration AR(Cmax) - MAD Cohorts | Accumulation ratio for maximum observed plasma concentration AR(Cmax) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants in MAD Cohorts that received Danicamtiv with plasma concertation data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
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| Secondary | Accumulation Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours AR(AUC(0-12)) - MAD Cohorts | Accumulation ratio for area under the plasma concentration-time curve from time 0 to 12 hours AR(AUC(0-12)) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants in MAD Cohorts that received Danicamtiv with plasma concertation data | Posted | Geometric Mean | Geometric Coefficient of Variation | hr x ng/mL | 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdose |
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| Secondary | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 1 - SAD Cohorts | Mean change from baseline in TTE parameter systolic ejection time (SET) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive | All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | Posted | Mean | Standard Error | msec | Baseline, predose and at 3, 6, 9, and 24 hours post dose |
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| Secondary | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 2 - SAD Cohorts | Mean change from baseline in TTE parameter left ventricular stroke volume (LVSV) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive | All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | Posted | Mean | Standard Error | mL | Baseline, predose and at 3, 6, 9, and 24 hours post dose |
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| Secondary | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - SAD Cohorts | Mean change from baseline in TTE parameter left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive | All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | Posted | Mean | Standard Error | Percentage of blood pumped from LV | Baseline, predose and at 3, 6, 9, and 24 hours post dose |
|
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| Secondary | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 1 - MAD Cohorts | Mean change from baseline in TTE parameter systolic ejection time (SET) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive | All treated participants in MAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | Posted | Mean | Standard Error | msec | Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11 |
|
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| Secondary | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 2 - MAD Cohorts | Mean change from baseline in TTE parameter left ventricular stroke volume (LVSV) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive | All treated participants in MAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | Posted | Mean | Standard Error | mL | Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11 |
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| Secondary | Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - MAD Cohorts | Mean change from baseline in TTE parameter left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive | All treated participants in MAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive) | Posted | Mean | Standard Error | Percentage of blood pumped from LV | Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11 |
|
Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAD Cohort 1 Danicamtiv 175mg | Participants received single dose of Danicamtiv 175mg in either period A, B, or C | 0 | 8 | 0 | 8 | 3 | 8 |
| EG001 | SAD Cohort 1 Danicamtiv 350mg | Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | SAD Cohort 1 Placebo | Participants received single dose of Placebo in either period A, B, or C | 0 | 8 | 0 | 8 | 3 | 8 |
| EG003 | SAD Cohort 1 Danicamtiv Optional Period D | Participants received Danicamtiv at either 450mg, 525mg or 550mg in period D | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg | 0 | 4 | 0 | 4 | 3 | 4 |
| EG005 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg | 0 | 4 | 0 | 4 | 0 | 4 |
| EG006 | SAD Cohort 2 Placebo | Participants received single dose of Placebo | 0 | 4 | 0 | 4 | 0 | 4 |
| EG007 | MAD Cohort 1 Danicamtiv 75mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 6 | 1 | 6 | 2 | 6 |
| EG008 | MAD Cohort 1 Placebo | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 2 | 0 | 2 | 0 | 2 |
| EG009 | MAD Cohort 2 Danicamtiv 50mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 9 | 0 | 9 | 7 | 9 |
| EG010 | MAD Cohort 2 Placebo | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 3 | 0 | 3 | 1 | 3 |
| EG011 | MAD Cohort 3 Danicamtiv 75mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 9 | 0 | 9 | 6 | 9 |
| EG012 | MAD Cohort 3 Placebo | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 3 | 0 | 3 | 1 | 3 |
| EG013 | MAD Cohort 4 Danicamtiv 100mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 6 | 0 | 6 | 5 | 6 |
| EG014 | MAD Cohort 4 Placebo | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge | 0 | 2 | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oral contusion | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Application site erosion | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion site discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram QRS complex prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Oct 21, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| SAEs |
|
| OG004 | SAD Cohort 1 Danicamtiv 525mg | Participants received single dose of Danicamtiv 525mg in period D |
| OG005 | SAD Cohort 1 Danicamtiv 550mg | Participants received split dose of Danicamtiv 550mg in period D |
| OG006 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg |
| OG007 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg |
| OG008 | SAD Cohort 2 Placebo | Participants received single dose of Placebo |
|
|
| OG003 | MAD Cohort Placebo | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
|
|
| OG004 |
| SAD Cohort 1 Danicamtiv 525mg |
Participants received single dose of Danicamtiv 525mg in period D |
| OG005 | SAD Cohort 1 Danicamtiv 550mg | Participants received split dose of Danicamtiv 550mg in period D |
| OG006 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg |
| OG007 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg |
| OG008 | SAD Cohort 2 Placebo | Participants received single dose of Placebo |
|
|
|
| SAD Cohort 1 Danicamtiv 525mg |
Participants received single dose of Danicamtiv 525mg in period D |
| OG005 | SAD Cohort 1 Danicamtiv 550mg | Participants received split dose of Danicamtiv 550mg in period D |
| OG006 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg |
| OG007 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg |
| OG008 | SAD Cohort 2 Placebo | Participants received single dose of Placebo |
|
|
|
|
|
|
|
|
| OG004 | SAD Cohort 1 Danicamtiv 525mg | Participants received single dose of Danicamtiv 525mg in period D |
| OG005 | SAD Cohort 1 Danicamtiv 550mg | Participants received split dose of Danicamtiv 550mg in period D |
| OG006 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg |
| OG007 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg |
| OG008 | MAD Cohort 2 Danicamtiv 50mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge |
| OG009 | MAD Cohort 1+3 Danicamtiv 75mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| OG010 | MAD Cohort 4 Danicamtiv 100mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
|
|
| SAD Cohort 1 Danicamtiv 525mg |
Participants received single dose of Danicamtiv 525mg in period D |
| OG005 | SAD Cohort 1 Danicamtiv 550mg | Participants received split dose of Danicamtiv 550mg in period D |
| OG006 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg |
| OG007 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg |
| OG008 | MAD Cohort 2 Danicamtiv 50mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge |
| OG009 | MAD Cohort 1+3 Danicamtiv 75mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| OG010 | MAD Cohort 4 Danicamtiv 100mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
|
|
| OG003 |
| SAD Cohort 1 Danicamtiv 350mg Period D |
Participants received single dose of Danicamtiv 350mg in period D |
| OG004 | SAD Cohort 1 Danicamtiv 525mg | Participants received single dose of Danicamtiv 525mg in period D |
| OG005 | SAD Cohort 1 Danicamtiv 550mg | Participants received split dose of Danicamtiv 550mg in period D |
| OG006 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg |
| OG007 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg |
| OG008 | MAD Cohort 2 Danicamtiv 50mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge |
| OG009 | MAD Cohort 1+3 Danicamtiv 75mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| OG010 | MAD Cohort 4 Danicamtiv 100mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
|
|
| SAD Cohort 1 Danicamtiv 525mg |
Participants received single dose of Danicamtiv 525mg in period D |
| OG005 | SAD Cohort 1 Danicamtiv 550mg | Participants received split dose of Danicamtiv 550mg in period D |
| OG006 | SAD Cohort 2 Danicamtiv 400mg | Participants received split dose of Danicamtiv 400mg |
| OG007 | SAD Cohort 2 Danicamtiv 500mg | Participants received split dose of Danicamtiv 500mg |
| OG008 | MAD Cohort 2 Danicamtiv 50mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge |
| OG009 | MAD Cohort 1+3 Danicamtiv 75mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
| OG010 | MAD Cohort 4 Danicamtiv 100mg | Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge. |
|
|
|
|
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
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