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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20210291 | Other Identifier | China CDE clinical trial registration |
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| Name | Class |
|---|---|
| Cytokinetics | INDUSTRY |
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The purposes of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CK-3773274 for Single Ascending Dose (SAD) Cohorts | Experimental | Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274 |
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| Placebo comparator for SAD Cohorts | Placebo Comparator | Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator |
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| CK-3773274 for Multiple Dose (MD) Cohort | Experimental | Subjects will receive multiple doses of CK-3773274 |
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| Placebo comparator for MD Cohort | Placebo Comparator | Subjects will receive multiple doses of placebo comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK-3773274 | Drug | CK-3773274- Tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE) | SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23 | |
| Reduced Left Ventricular Ejection Fraction (LVEF) | SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of CK-3773274 after single and multiple ascending doses | SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen, MD | Corxel Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37680714 | Derived | Zhao X, Liu H, Tian W, Fang L, Yu M, Wu X, Liu A, Wan R, Li L, Luo J, Li Y, Liu B, He Y, Chen X, Li Y, Xu D, Wang H, Han X. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of aficamten in healthy Chinese participants: a randomized, double-blind, placebo-controlled, phase 1 study. Front Pharmacol. 2023 Aug 23;14:1227470. doi: 10.3389/fphar.2023.1227470. eCollection 2023. |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| Placebo | Drug | Placebo- Tablets |
|
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |