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Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period.
Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period. After the 28 day screening period, the eligible subject will be admitted to the clinical site and will receive a single dose of study drug or placebo. Subjects will be confined to the clinical site for five days (Day -1 to Day 4) and will return to the clinic on Day 7 for a safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single oral dose of MYK-491 | Experimental | single-dose, oral suspension |
|
| Single oral dose of placebo | Placebo Comparator | single-dose, oral suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYK-491 or placebo | Drug | Oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessments will include treatment emergent AEs and SAEs, ECG recordings, vital signs, hs-troponin 1 concentrations, laboratory abnormalities and physical exam abnormalities | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma drug concentration (Cmax) | 7 days | |
| Maximum observed plasma concentration (Tmax) | 7 days | |
| Area under the plasma concentration-time curve (AUC) |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in LVFS, LVEF, LVSV and SET by TTE | 7 days | |
| SET while using photoplethysmography | 7 days | |
| Relationship between MYK-491 plasma concentrations/PK parameters and PD parameters |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lickliter, MD | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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Subjects will be randomized 6:2 to MYK-491:placebo within each cohort.
| 7 days |
| First-order terminal elimination half-life (t1/2) | 7 days |
| Mean retention time (MRT) | 7 days |
| 7 days |
| Plasma concentrations of metabolites of MYK-491 in plasma and urine | 7 days |
| Relationship between MYK-491 plasma concentration and QTc interval | 7 days |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |