Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy (NCT NCT05556343)
NCT ID: NCT05556343
Last Updated: 2026-06-02
Results Overview
LVEF was assessed using transthoracic echocardiogram (TTE) in resting state. 90% CIs are calculated based on Exact Binomial proportion test. LVEF value was calculated by Simpson Biplane method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Results posted on
2026-06-02
Participant Flow
Participant milestones
| Measure |
Part A - Dose Treatment - MYK-224
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
Part B - Open Label Extension - MYK-224
All participants received MYK-224 as a once-daily oral dose. Treatment administration, consisting of either MYK-224 alone or MYK-224 in combination with beta blockers, began on Day 1B. Each participant received the same dose completed in Part A, unless there were changes to background HCM therapy after Part A. The planned study drug exposure was approximately 108 weeks. The actual median duration of exposure in Part B was 51.90 weeks. Minimum exposure was 28.7 weeks and maximum was 64.1 weeks.
|
|---|---|---|
|
Part A - Dose Treatment
STARTED
|
18
|
0
|
|
Part A - Dose Treatment
COMPLETED
|
17
|
0
|
|
Part A - Dose Treatment
NOT COMPLETED
|
1
|
0
|
|
Part B - Open Label Extension
STARTED
|
0
|
16
|
|
Part B - Open Label Extension
COMPLETED
|
0
|
0
|
|
Part B - Open Label Extension
NOT COMPLETED
|
0
|
16
|
Reasons for withdrawal
| Measure |
Part A - Dose Treatment - MYK-224
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
Part B - Open Label Extension - MYK-224
All participants received MYK-224 as a once-daily oral dose. Treatment administration, consisting of either MYK-224 alone or MYK-224 in combination with beta blockers, began on Day 1B. Each participant received the same dose completed in Part A, unless there were changes to background HCM therapy after Part A. The planned study drug exposure was approximately 108 weeks. The actual median duration of exposure in Part B was 51.90 weeks. Minimum exposure was 28.7 weeks and maximum was 64.1 weeks.
|
|---|---|---|
|
Part A - Dose Treatment
Other reasons
|
1
|
0
|
|
Part B - Open Label Extension
Study terminated by sponsor
|
0
|
16
|
Baseline Characteristics
Analysis only included for participants with data available at the baseline
Baseline characteristics by cohort
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 9.08 • n=18 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
|
BACKGROUND HCM THERAPY
BETA BLOCKER USE AT BASELINE
|
9 Participants
n=18 Participants
|
|
BACKGROUND HCM THERAPY
CALCIUM CHANNEL BLOCKER USE AT BASELINE
|
0 Participants
n=18 Participants
|
|
BACKGROUND HCM THERAPY
DISOPYRAMIDE USE AT BASELINE
|
0 Participants
n=18 Participants
|
|
BACKGROUND HCM THERAPY
NONE
|
9 Participants
n=18 Participants
|
|
Implantable Cardioverter Defibrillator (ICD) Therapy Use
Yes
|
5 Participants
n=18 Participants
|
|
Implantable Cardioverter Defibrillator (ICD) Therapy Use
No ICD use
|
13 Participants
n=18 Participants
|
|
NYHA FUNCTIONAL CLASS
CLASS I
|
1 Participants
n=18 Participants
|
|
NYHA FUNCTIONAL CLASS
CLASS II
|
12 Participants
n=18 Participants
|
|
NYHA FUNCTIONAL CLASS
CLASS III
|
5 Participants
n=18 Participants
|
|
NYHA FUNCTIONAL CLASS
CLASS IV
|
0 Participants
n=18 Participants
|
|
LEFT VENTRICULAR EJECTION FRACTION
|
65.4 percentage
STANDARD_DEVIATION 4.23 • n=18 Participants
|
|
LVOT PEAK GRADIENT FOR RESTING
|
74.516 mmHg
STANDARD_DEVIATION 35.5013 • n=18 Participants
|
|
LVOT PEAK GRADIENT FOR VALSALVA
|
94.968 mmHg
STANDARD_DEVIATION 35.6349 • n=18 Participants
|
|
LVOT PEAK GRADIENT FOR POST-EXERCISE
|
93.626 mmHg
STANDARD_DEVIATION 38.6472 • n=18 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (23-item version) Clinical Summary Score
|
73.9583 Score on a Scale
n=14 Participants • Analysis only included for participants with data available at the baseline
|
|
NT-PROBNP
|
660.0 Pg/ml
n=18 Participants
|
|
Medical History
Atrial Fibrillation
|
5 Participants
n=18 Participants
|
|
Medical History
Coronary Artery Disease
|
3 Participants
n=18 Participants
|
|
Medical History
Diabetes Mellitus
|
3 Participants
n=18 Participants
|
|
Medical History
Hypertension
|
8 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Number of Participants With Adverse Events and Serious Adverse Events
Participants with at least one adverse events in Part A
|
15 Participants
|
|
Part A: Number of Participants With Adverse Events and Serious Adverse Events
Participants with at least one serious adverse events in Part A
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A.
Arrhythmias included atrial fibrillation/flutter (new from screening and recurrent), ventricular tachyarrhythmias (ventricular tachycardia, ventricular fibrillation, and Torsades de Pointe).
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Number of Participants With at Least One Event of Arrhythmias
Atrial Fibrillation/Flutter
|
2 Participants
|
|
Part A: Number of Participants With at Least One Event of Arrhythmias
Ventricular Tachyarrhythmias
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Number of Participants With at Least One Event of Appropriate Implantable Cardioverter Defibrillator Therapy and Resuscitated Cardiac Arrest
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A. Only participants with data available at the specified timepoint are included in the analysis.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Heart rate was measured in rested state.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Vital Signs - Heart Rate
|
0.9 beats per minute
Standard Deviation 8.96
|
PRIMARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A. Only participants with data available at the specified timepoint are included in the analysis.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Systolic blood pressure was measured in rested state.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Vital Signs - Mean Systolic Blood Pressure
|
2.5 mmHg
Standard Deviation 18.25
|
PRIMARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A. Only participants with data available at the specified timepoint are included in the analysis.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Diastolic blood pressure was measured in rested state.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Vital Signs - Mean Diastolic Blood Pressure
|
4.2 mmHg
Standard Deviation 12.62
|
PRIMARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A. Only participants with data available at the specified timepoint are included in the analysis.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Respiratory rate was measured in rested state.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Vital Signs - Respiratory Rate
|
0.6 breaths per minute
Standard Deviation 2.23
|
PRIMARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A. Only participants with data available at the specified timepoint are included in the analysis.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=17 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Vital Signs - Temperature
|
-0.09 Celsius
Standard Deviation 0.280
|
PRIMARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A. Only participants with data available at the specified timepoint are included in the analysis.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Vital Signs - Weight
|
0.89 kilogram
Standard Deviation 3.168
|
PRIMARY outcome
Timeframe: Baseline and until study end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A.
The complete physical examination included weight and calculated BMI, a neurological examination (gross motor and deep tendon reflexes),and an assessment of the following: general appearance, skin, head and neck, mouth, lymph nodes, thyroid, abdomen, musculoskeletal, cardiovascular, neurological, and respiratory systems with other systems included, as directed by interval history.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Number of Participants With Abnormal Physical Examination Results
Cardiovascular
|
11 Participants
|
|
Part A: Number of Participants With Abnormal Physical Examination Results
Skin
|
1 Participants
|
|
Part A: Number of Participants With Abnormal Physical Examination Results
Other
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and until study end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A. Only participants with data available at the specified timepoint are included in the analysis.
Twelve-lead ECG evaluations will be performed in the supine position after 10 minutes of rest at Screening and at selected clinic visits prior to MYK-224 dosing and before any blood sample collection. QTc prolongation is defined by either the mean of QTcF \> 499 or mean of QTcB \> 499 according to the project requirement specification from Clario.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=17 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
ST DEPRESSION (end date)
|
2 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
T WAVES FLAT (Baseline)
|
1 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
T WAVES FLAT (end date
|
1 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
T WAVE INVERSION (Baseline)
|
7 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
QTC PROLONGATION (Baseline)
|
3 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
QTC PROLONGATION (end date)
|
2 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
ST DEPRESSION (Baseline)
|
4 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
T WAVE INVERSION (end date)
|
3 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
ATRIAL FIBRILLATION/FLUTTER (Baseline)
|
5 Participants
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
ATRIAL FIBRILLATION/FLUTTER (End date)
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and untill end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A.
Blood samples were collected to assess the clinical laboratory parameters.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Number of Participants With Adverse Events Related to Clinical Laboratory Parameters (Hematology, Chemistry and Urinalysis)
Chemistry (Elevated Alanine Aminotransferase)
|
1 Participants
|
|
Part A: Number of Participants With Adverse Events Related to Clinical Laboratory Parameters (Hematology, Chemistry and Urinalysis)
Chemistry (Transaminases increased)
|
1 Participants
|
|
Part A: Number of Participants With Adverse Events Related to Clinical Laboratory Parameters (Hematology, Chemistry and Urinalysis)
Hematology
|
0 Participants
|
|
Part A: Number of Participants With Adverse Events Related to Clinical Laboratory Parameters (Hematology, Chemistry and Urinalysis)
Urinalysis
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A.
LVEF was assessed using transthoracic echocardiogram (TTE) in resting state. 90% CIs are calculated based on Exact Binomial proportion test. LVEF value was calculated by Simpson Biplane method.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A:Percentage of Participants With Incidence of Symptomatic Left Ventricular Ejection Fraction (LVEF) < 50%
|
0 percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)Population: Safety A population consist of all enrolled participants who received at least 1 dose of MYK-224. Pre-specified to be analyzed for Part A.
LVEF was assessed using transthoracic echocardiogram (TTE) in resting state. 90% CIs are calculated based on Exact Binomial proportion test. LVEF value was calculated by Simpson Biplane method.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Percentage of Participants With Incidence of Symptomatic Left Ventricular Ejection Fraction (LVEF) <= 30%
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Efficacy/PD A population included All enrolled A participants who receive at least 1 dose of MYK-224 and have primary or secondary endpoint data, including a baseline value and at least 1 post-baseline value Pre-specified to be analyzed for Part A.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=15 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Aggregate Mean of Left Ventricular Ejection Fraction (LVEF)
|
65.0 percentage
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Efficacy/PD A population included All enrolled A participants who receive at least 1 dose of MYK-224 and have primary or secondary endpoint data, including a baseline value and at least 1 post-baseline value Pre-specified to be analyzed for Part A.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Participants with data available at the timepoint were included in the analysis.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=15 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
|
0.1 percentage
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Efficacy/PD A population included All enrolled A participants who receive at least 1 dose of MYK-224 and have primary or secondary endpoint data, including a baseline value and at least 1 post-baseline value Pre-specified to be analyzed for Part A.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Aggregate Mean of Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Resting LVOT
|
25.423 mmHg
Standard Deviation 23.5685
|
|
Part A: Aggregate Mean of Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Valsalva LVOT
|
43.888 mmHg
Standard Deviation 36.1765
|
|
Part A: Aggregate Mean of Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Post-Exercise LVOT
|
56.965 mmHg
Standard Deviation 45.1914
|
SECONDARY outcome
Timeframe: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Efficacy/PD A population included All enrolled A participants who receive at least 1 dose of MYK-224 and have primary or secondary endpoint data, including a baseline value and at least 1 post-baseline value Pre-specified to be analyzed for Part A.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Participants with data available at the timepoint were included in the analysis.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Change From Baseline in Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Resting LVOT
|
-49.093 mmHg
Standard Deviation 30.9153
|
|
Part A: Change From Baseline in Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Valsalva LVOT
|
-51.079 mmHg
Standard Deviation 36.1091
|
|
Part A: Change From Baseline in Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Post-Exercise LVOT
|
-34.654 mmHg
Standard Deviation 43.1174
|
SECONDARY outcome
Timeframe: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Efficacy/PD A population included All enrolled A participants who receive at least 1 dose of MYK-224 and have primary or secondary endpoint data, including a baseline value and at least 1 post-baseline value Pre-specified to be analyzed for Part A.
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. 90%CIs are calculated based on Normal approximation.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Percentage of Participants With Resting Left Ventricular Outflow Tract (LVOT) Peak Gradient < 30 mmHg and Valsalva LVOT Peak Gradient < 50 mmHg
|
61.1 percentage of participants
Interval 42.21 to 80.01
|
SECONDARY outcome
Timeframe: Pre-dose and 1 hour post-dose end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)Population: Evaluable PK Analysis Population - Part A included All enrolled A participants who received at least 1 dose of MYK-224 and have at least 1 evaluable PK concentration. Pre-specified to be analyzed for Part A.
Blood samples were collected to assess plasma concentration of MYK-224.
Outcome measures
| Measure |
Part A - Dose Treatment - MYK-224
n=18 Participants
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
|---|---|
|
Part A: Plasma Concentration of MYK-224
MYK-224 Monotherapy - Pre-Dose
|
189.113 ng/mL
Geometric Coefficient of Variation 65.6285
|
|
Part A: Plasma Concentration of MYK-224
MYK-224 + Beta Blockers - Pre-Dose
|
136.926 ng/mL
Geometric Coefficient of Variation 111.1556
|
|
Part A: Plasma Concentration of MYK-224
MYK-224 + Beta Blockers - 1 hour Post-dose
|
199.685 ng/mL
Geometric Coefficient of Variation 92.7083
|
|
Part A: Plasma Concentration of MYK-224
MYK-224 Monotherapy, 1 hour Post-dose
|
280.621 ng/mL
Geometric Coefficient of Variation 49.9295
|
Adverse Events
Part A - Dose Treatment - MYK-224
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Part B - Open Label Extension - MYK-224
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - Dose Treatment - MYK-224
n=18 participants at risk
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
Part B - Open Label Extension - MYK-224
n=16 participants at risk
All participants received MYK-224 as a once-daily oral dose. Treatment administration, consisting of either MYK-224 alone or MYK-224 in combination with beta blockers, began on Day 1B. Each participant received the same dose completed in Part A, unless there were changes to background HCM therapy after Part A. The planned study drug exposure was approximately 108 weeks. The actual median duration of exposure in Part B was 51.90 weeks. Minimum exposure was 28.7 weeks and maximum was 64.1 weeks.
|
|---|---|---|
|
Nervous system disorders
Epilepsy
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
Other adverse events
| Measure |
Part A - Dose Treatment - MYK-224
n=18 participants at risk
Participants with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction and who took or did not take Beta blockers at or before baseline received MYK-224. Dosing consisted of a once-daily oral dose in the form of tablets. All participants began at an initial dose of 5 mg of MYK-224, followed by up-or down-titration to doses between 2.5mg and 50mg. Dose titration was based on TTE measures taken at 3 weeks (at least 21 days) post-initiation of each new dose. Participants were to repeat this 4-week period as needed to identify their individual target dose. Once the individual dose was identified, participants were to continue dosing until the following 2 criteria were met: 6 weeks (at least 42 days) total dosing at their target dose (including the 4-week titration phase, if applicable) and an overall minimum total treatment period of 12 weeks (at least 84 days) at any dose or combination of doses.
|
Part B - Open Label Extension - MYK-224
n=16 participants at risk
All participants received MYK-224 as a once-daily oral dose. Treatment administration, consisting of either MYK-224 alone or MYK-224 in combination with beta blockers, began on Day 1B. Each participant received the same dose completed in Part A, unless there were changes to background HCM therapy after Part A. The planned study drug exposure was approximately 108 weeks. The actual median duration of exposure in Part B was 51.90 weeks. Minimum exposure was 28.7 weeks and maximum was 64.1 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
2/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Cardiac disorders
Angina pectoris
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Cardiac disorders
Sinus bradycardia
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Cardiac disorders
Ventricular tachycardia
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Endocrine disorders
Hyperthyroidism
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Eye disorders
Presbyopia
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
General disorders
Chest discomfort
|
11.1%
2/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
General disorders
Fatigue
|
22.2%
4/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
General disorders
Peripheral swelling
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Infections and infestations
Gastroenteritis viral
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Infections and infestations
Influenza
|
22.2%
4/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Infections and infestations
Laryngitis
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Infections and infestations
Respiratory tract infection
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Infections and infestations
Viral infection
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Investigations
Transaminases increased
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Nervous system disorders
Cervical radiculopathy
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Nervous system disorders
Dizziness
|
22.2%
4/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Nervous system disorders
Dizziness postural
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Psychiatric disorders
Libido decreased
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Psychiatric disorders
Loss of libido
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
38.9%
7/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
0.00%
0/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Eye disorders
Cataract
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
General disorders
Pyrexia
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/18 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
6.2%
1/16 • All cause mortality and adverse events were collected from from first dose (Day 1) until study end date in Part A or B or 30 days after early termination date (Median 69.05 weeks and Maximum 85.0 weeks)
Adverse events were collected for safety population in which participant received at least one dose of MYK-224
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER