Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2007-04-30
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Cohort 1
4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
CK-1827452
IV infusion for 1 hour at 0.125 mg/kg/h followed by 1 hour at 0.0625 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h
Placebo
IV infusion for 2 hours
Cohort 2
4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
CK-1827452
IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.75 mg/kg/h followed by 1 hour at 0.375 mg/kg/h
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h
Placebo
IV infusion for 2 hours
Cohort 3
4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
Placebo
IV infusion for 24 hours
CK-1827452
IV infusion for 1 hour at 0.25 mg/kg/h followed by 23 hours at 0.025 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.5 mg/kg/h followed by 23 hours at 0.05 mg/kg/h
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed by 23 hours at 0.1 mg/kg/h
Cohort 4
4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
CK-1827452
IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h followed by 22 hours at 0.025 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h followed by 22 hours at 0.05 mg/kg/h
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h followed by 22 hours at 0.1 mg/kg/h
Placebo
IV infusion for 24 hours
Cohort 5
2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
Placebo
IV infusion for 72 hours
CK-1827452
IV infusion for 1 hour at 0.75 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
Interventions
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CK-1827452
IV infusion for 1 hour at 0.125 mg/kg/h followed by 1 hour at 0.0625 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.75 mg/kg/h followed by 1 hour at 0.375 mg/kg/h
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h followed by 22 hours at 0.025 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h followed by 22 hours at 0.05 mg/kg/h
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h followed by 22 hours at 0.1 mg/kg/h
Placebo
IV infusion for 2 hours
Placebo
IV infusion for 24 hours
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
Placebo
IV infusion for 72 hours
CK-1827452
IV infusion for 1 hour at 0.75 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.25 mg/kg/h followed by 23 hours at 0.025 mg/kg/h
CK-1827452
IV infusion for 1 hour at 0.5 mg/kg/h followed by 23 hours at 0.05 mg/kg/h
CK-1827452
IV infusion for 1 hour at 1.0 mg/kg/h followed by 23 hours at 0.1 mg/kg/h
Eligibility Criteria
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Inclusion Criteria
2. Female patients must have a negative urine pregnancy test prior to entry into the study
3. Patient is 18 years old or greater
4. Patient has given signed informed consent
5. Patient is considered to be in suitable health in the opinion of the investigator, as determined by:
* A pre-study physical examination with no clinical abnormalities which in the opinion of the investigator would preclude participation in the study other than physical symptoms or signs consistent with stable heart failure
* An electrocardiogram (ECG) with no abnormalities in the opinion of the investigator that would impair assessment of stopping criteria
Exclusion Criteria
8. Patient has been on a stable dose of a beta blocker and an ACE (angiotensin-converting enzyme) inhibitor or an ARB (angiotensin II receptor blocker) for at least 4 weeks. If prescribed, diuretics must have been administered according to a consistent regimen for at least 4 weeks
9. Patient is currently in sinus rhythm
10. Patient has interpretable echocardiographic images on a screening echocardiogram
1. Patient has been hospitalized for heart failure, myocardial infarction, coronary revascularization, or another cardiac indication within the last 6 weeks
2. Patient has a current history of alcohol use which in the opinion of the investigator would preclude participation in the study
3. Patient has a current history of drug abuse
4. Patient has donated blood or blood products within 30 days prior to screening
5. Patient has Canadian Cardiovascular Society (CCS) Class III or IV angina
6. Patient has significant obstructive valvular disease or significant congenital heart disease
7. Patient has had a valve replacement
8. Patient is pacemaker dependent
9. Patient is on chronic anti-arrhythmic therapy, with the exception of amiodarone
10. Patient is currently taking, or has taken in the last 7 days, a CYP3A4 inhibitor or inducer medication
11. Patient has a history of hypertrophic obstructive cardiomyopathy
12. Patient weighs \> 120 kg
13. Patient has a supine resting systolic blood pressure \< 95 mmHg after 3 minutes rest
14. Patient has a supine resting heart rate ≥ 100 beats per minute after 3 minutes rest
15. Patient has an Modification of Diet in Renal Disease (MDRD) estimate of Glomerular Filtration Rate (GFR) ≤ 35 ml/min/1.73 m2
16. Patient has a potassium \< 3.5 mEq/L or \> 5.5 mEq/L
17. Patient has a sodium ≤ 133 mEq/L
18. Patient has a urea \> 15 mmole/L
19. Patient has a troponin I or T at screening that is detectable at the investigative site's clinical laboratory
20. Patient has a hemoglobin \< 11 gm/dL in males or \< 10 gm/dL in females
21. Patient has an alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALKP) or total bilirubin (TBILI) \> 3 times the upper limit of normal
22. Patient is, in the opinion of the investigator, not suitable to participate in the study
23. Patient has participated in any clinical study with an investigational drug within three months prior to the first day of dosing with the exception of coronary stent studies Patient has ever received CK-1827452
18 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Locations
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University of California, San Diego Medical Center
San Diego, California, United States
Christiana Care Health Services, Inc.
Newark, Delaware, United States
Diagnostic Services Clinic
Tbilisi, , Georgia
Russian Cardiological Research and Production Complex
Moscow, , Russia
Dzhanelidze Research Institute for Emergency Medical Care
Saint Petersburg, , Russia
Almazov Federal Heart, Blood and Endocrinology Center
Saint Petersburg, , Russia
St. Petersburg State Medical University
Saint Petersburg, , Russia
Castle Hill Hospital, University of Hull
Hull, England, United Kingdom
King's College Hospital
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
St. Mary's Hospital & Imperial College
London, England, United Kingdom
Manchester Heart Centre, Manchester Royal Infirmary
Manchester, England, United Kingdom
ICON Development Solutions
Manchester, England, United Kingdom
Wythenshawe Hospital
Manchester, England, United Kingdom
Northwick Park Hospital
Middlesex, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
BHF Cardiovascular Centre
Glasgow, Scotland, United Kingdom
Countries
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References
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Vu T, Ma P, Xiao JJ, Wang YM, Malik FI, Chow AT. Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure. J Clin Pharmacol. 2015 Nov;55(11):1236-47. doi: 10.1002/jcph.538. Epub 2015 Jul 14.
Cleland JG, Teerlink JR, Senior R, Nifontov EM, Mc Murray JJ, Lang CC, Tsyrlin VA, Greenberg BH, Mayet J, Francis DP, Shaburishvili T, Monaghan M, Saltzberg M, Neyses L, Wasserman SM, Lee JH, Saikali KG, Clarke CP, Goldman JH, Wolff AA, Malik FI. The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure: a double-blind, placebo-controlled, crossover, dose-ranging phase 2 trial. Lancet. 2011 Aug 20;378(9792):676-83. doi: 10.1016/S0140-6736(11)61126-4.
Other Identifiers
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CY 1121
Identifier Type: -
Identifier Source: org_study_id
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