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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03767855 | A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects | PHASE1 | COMPLETED | 114 | — | — | Dec 4, 2018 | Jan 3, 2020 | Jan 24, 2025 | 1 | United States |
Subject incidence of AEs, SAEs, and reduced LVEF
| Arm | Type | Description |
|---|---|---|
| CK-3773274 for SAD Cohorts | EXPERIMENTAL | Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-3773274 |
| Placebo for SAD Cohorts | PLACEBO_COMPARATOR | Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of placebo |
| CK-3773274 for MAD Cohorts | EXPERIMENTAL | Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of CK-3773274 |
| Placebo for MAD Cohorts | PLACEBO_COMPARATOR | Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of placebo |
| CK-3773274 for CYP2D6 Cohort | EXPERIMENTAL | Subjects with CYP2D6 poor metabolizer phenotype will be assigned to receive a single dose of CK-3773274 |
| Placebo for CYP2D6 Cohort | PLACEBO_COMPARATOR | Subjects with CYP2D6 poor metabolizer phenotype will be assigned to receive a single dose of placebo |
| Food Effect | EXPERIMENTAL | Subjects will be administered CK-3773274 with and without food in a randomized cross-over fashion |
| Relative Bioavailability | EXPERIMENTAL | Subjects will be administered CK-3773274 as granules in a capsule and as a tablet in a randomized cross-over fashion. |
| Name | Type | Description |
|---|---|---|
| CK-3773274 - Granules in Capsule | DRUG | CK-3773274 formulated as granules in capsule |
| Placebo - Granules in Capsule | DRUG | Placebo formulated as granules in capsule |
| CK-3773274 - Tablets | DRUG | CK-3773274 formulated as tablets |
Inclusion Criteria: 1. Males and females (of non-childbearing potential) between 18 and 55 years of age, inclusive 2. Body weight \> 55.0 kg and body mass index within 18.0 to 32.0 kg/m2, inclusive 3. Normal cardiac structure and function, or if abnormalities are present, they are deemed not clinic...