Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02480296 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers | PHASE1 | COMPLETED | 60 | — | — | Aug 1, 2015 | Oct 1, 2016 | Mar 22, 2017 | 1 | Australia |
| NCT02356289 | Single Ascending Dose Study of MYK-461 in Healthy Volunteers | PHASE1 | COMPLETED | 48 | — | — | Jan 1, 2015 | Jul 1, 2015 | Sep 23, 2015 | 1 | United Kingdom |
Incidence of adverse events
| Arm | Type | Description |
|---|---|---|
| MYK-461 | EXPERIMENTAL | Oral Tablet x 28 days |
| Placebo | PLACEBO_COMPARATOR | Oral Tablet x 28 days |
| Name | Type | Description |
|---|---|---|
| MYK-461 | DRUG | - |
| Placebo | DRUG | Placebo comparator |
Inclusion Criteria: * Normal body mass index (BMI) * Normal LVEF * Normal electrocardiogram (ECG) * Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug Exclus...