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Terminated early per sponsor decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CK-3828136 for SAD Cohort | Experimental | Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136 |
|
| Placebo for SAD Cohort | Placebo Comparator | Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo |
|
| CK-3828136 for MAD Cohort | Experimental | Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136 |
|
| Placebo for MAD Cohort | Placebo Comparator | Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo |
|
| Food Effect | Experimental | Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK-3828136 | Drug | CK-3828136 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs | To assess the safety and tolerability of CK-3828136 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-3828136 including AUC | To characterize the PK of CK-3828136 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:
Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated:
History of any significant illness or disorder.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed).
History or presence of:
Clinically significant illness within 4 weeks prior to check in.
Participants with an inability to swallow tablets.
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| Name | Affiliation | Role |
|---|---|---|
| Cytokinetics, MD | Cytokinetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc. | Dallas | Texas | 75247 | United States |
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| Placebo for CK-3828136 | Drug | Placebo for CK-3828136 |
|
| 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-3828136 in healthy participants Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14 |
| Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14 |
| PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state | PK parameters following single multiple doses in fed and fasted state | Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2) |