Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to understand the pharmacokinetics of different oral formulations of CK-1827452 being considered for future studies in patients with heart failure. This study will compare the pharmacokinetics and safety and tolerability of both modified-release (MR) and immediate-release (IR) oral formulations of CK-1827452.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: MR 50 mg BID | Experimental | Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. |
|
| Cohort 2: IR 37.5 mg TID | Experimental | Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. |
|
| Cohort 3: MR 100 mg BID | Experimental | Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK-1827452 | Drug | 50 mg MR CK-1827452 BID for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| C Max (Day 1, Dose 1) | Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2. | 1 day |
| T Max (Day 1, Dose 1) | Time of observed maximum plasma concentration (T max) measured in hours (hr) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2. | 1 day |
| AUC (Day 1, Dose 1) | Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2. | 1 day |
| C Max (Day 10) | Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study). | 1 day |
| T Max (Day 10) | Time of observed maximum plasma concentration (T max) measured in hours (hr) post dose on day 10. Only one dose was administered on day 10 (final dose of study). | 1 day |
| AUC (Day 10) | Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study). | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure. | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardio-Reanimation Centre | Tbilisi | Georgia | ||||
| Diagnostic Services Clinic |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: MR 50 mg BID | Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. |
| FG001 | Cohort 2: IR 37.5 mg TID | Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. |
| FG002 | Cohort 3: MR 100 mg BID | Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: MR 50 mg BID | Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. |
| BG001 | Cohort 2: IR 37.5 mg TID | Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | C Max (Day 1, Dose 1) | Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2. | PK population (4 patients excluded from cohort 3 analysis due to improper dosing). | Posted | Mean | Standard Deviation | ng/mL | 1 day |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: MR 50 mg BID | Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death | General disorders | MedRA 10.0 | Non-systematic Assessment | Reported as unrelated to treatment by Investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Cytokinetics, Inc. | 650-624-2918 |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C547293 | omecamtiv mecarbil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CK-1827452 |
| Drug |
37.5 mg IR CK-1827452 TID for 10 days |
|
| CK-1827452 | Drug | 100 mg MR CK-1827452 BID for 10 days |
|
| Tbilisi |
| Georgia |
| Tbilisi State Medical University Clinic #1 | Tbilisi | Georgia |
| BG002 | Cohort 3: MR 100 mg BID | Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Cohort 3: MR 100 mg BID | Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days |
|
|
| Secondary | Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure. | Not Posted | 1 week |
| Primary | T Max (Day 1, Dose 1) | Time of observed maximum plasma concentration (T max) measured in hours (hr) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2. | PK population (4 patients excluded from cohort 3 analysis due to improper dosing). | Posted | Mean | Standard Deviation | hr | 1 day |
|
|
|
| Primary | AUC (Day 1, Dose 1) | Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2. | PK population (4 patients excluded from cohort 3 analysis due to improper dosing). | Posted | Mean | Standard Deviation | hr*ng/mL | 1 day |
|
|
|
| Primary | C Max (Day 10) | Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study). | PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death). | Posted | Mean | Standard Deviation | ng/mL | 1 day |
|
|
|
| Primary | T Max (Day 10) | Time of observed maximum plasma concentration (T max) measured in hours (hr) post dose on day 10. Only one dose was administered on day 10 (final dose of study). | PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death). | Posted | Mean | Standard Deviation | hr | 1 day |
|
|
|
| Primary | AUC (Day 10) | Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study). | PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death). | Posted | Mean | Standard Deviation | hr*ng/mL | 1 day |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Cohort 2: IR 37.5 mg TID | Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. | 1 | 11 | 0 | 11 |
| EG002 | Cohort 3: MR 100 mg BID | Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days | 0 | 12 | 2 | 12 |
|
| Influenza like illness | General disorders | MedRA 10.0 | Systematic Assessment |
|
Sponsor intends to publish the results of the trial in collaboration with the Investigators.