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The purposes of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CK-4021586 for SAD Cohort | Experimental | Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586 |
|
| Placebo for SAD Cohort | Placebo Comparator | Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo |
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| CK-4021586 for MAD Cohort | Experimental | Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586 |
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| Placebo for MAD Cohort | Placebo Comparator | Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo |
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| Food Effect | Experimental | Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK-4021586 | Drug | CK-4021586 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs | To assess the safety and tolerability of CK-4021586 when administered orally as single or multiple doses to healthy participants | Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary PK parameters of CK-4021586 including AUC | To characterize the PK of CK-4021586 and CK-4022235 after single and multiple oral doses in healthy participants | Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scientific Leadership at Cytokinetics | Cytokinetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| Placebo for CK-4021586 | Drug | Placebo for CK-4021586 |
|
| Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF |
To characterize the PD effects of single and multiple oral doses of CK-4021586 in healthy participants |
| Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14 |