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Pharmacokinetics of Oral CK-1827452 in Patients With Stable Heart Failure

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ClinicalTrials.gov Identifier: NCT00941681
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : December 21, 2010
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Tracking Information
First Submitted Date  ICMJE July 15, 2009
First Posted Date  ICMJE July 17, 2009
Results First Submitted Date  ICMJE October 29, 2010
Results First Posted Date  ICMJE December 21, 2010
Last Update Posted Date February 12, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
  • C Max (Day 1, Dose 1) [ Time Frame: 1 day ]
    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.
  • T Max (Day 1, Dose 1) [ Time Frame: 1 day ]
    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.
  • AUC (Day 1, Dose 1) [ Time Frame: 1 day ]
    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.
  • C Max (Day 10) [ Time Frame: 1 day ]
    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).
  • T Max (Day 10) [ Time Frame: 1 day ]
    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).
  • AUC (Day 10) [ Time Frame: 1 day ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
The primary objective of this study is to evaluate the steady-state pharmacokinetics of oral formulations of CK-1827452 in patients with stable heart failure. [ Time Frame: 1 week ]
Change History Complete list of historical versions of study NCT00941681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure. [ Time Frame: 1 week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
The secondary objective of this study is to evaluate the safety and tolerability of oral formulations of CK-1827452 when dosed to steady-state in patients with stable heart failure. [ Time Frame: 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Oral CK-1827452 in Patients With Stable Heart Failure
Official Title  ICMJE An Open Label Study to Investigate the Pharmacokinetics of CK-1827452 Administered Orally to Patients With Stable Heart Failure
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: CK-1827452
    50 mg MR CK-1827452 BID for 10 days
  • Drug: CK-1827452
    37.5 mg IR CK-1827452 TID for 10 days
  • Drug: CK-1827452
    100 mg MR CK-1827452 BID for 10 days
Study Arms  ICMJE
  • Experimental: Cohort 1: MR 50 mg BID
    Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
    Intervention: Drug: CK-1827452
  • Experimental: 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.
    Intervention: Drug: CK-1827452
  • Experimental: Cohort 3: MR 100 mg BID
    Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
    Intervention: Drug: CK-1827452
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2010)
35
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
32
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient has signed an Informed Consent Form/Patient Information Sheet for this study approved by the governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
  2. The patient is at least 18 years old at the time of consent
  3. Left ventricular ejection fraction (LVEF) ≤ 35% as determined by the Investigator within 3 weeks prior to enrollment
  4. Treated for at least 4 weeks with a beta blocker and an ACE inhibitor (and/or an ARB) unless not tolerated. If prescribed, diuretics must have been administered according to a consistent regimen for at least 4 weeks.
  5. Diagnosed with heart failure for ≥ 3 months prior to enrollment
  6. Patient is considered to be an appropriate candidate for study enrollment as determined by the patient's clinical laboratory findings, vital signs and ECGs within normal range, or if outside of the normal range not deemed clinically significant in the opinion of the Investigator
  7. For female patients only: The patient is post-menopausal (≥ 1 year) or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant during the course of the study, and she is using contraceptive drugs or devices. For male patients only: Male patients agree for the duration of the study and 10 weeks after the end of the study to use a condom during sexual intercourse with female partners who are of reproductive potential and to have female partners use an additional effective means of contraception (eg, diaphragm plus spermicide, or oral contraceptives) or the male subject must agree to abstain from sexual intercourse for 10 weeks after the end of the study.

Exclusion Criteria:

  1. Patient has been hospitalised for heart failure, acute coronary syndrome, myocardial infarction, coronary revascularisation, transient ischemic attack or stroke, cardiac arrhythmia, or major surgery within 6 weeks prior to enrollment
  2. Poorly controlled hypertension defined as blood pressure > 150/95 mmHg, documented on at least 2 separate occasions prior to enrollment
  3. The patient has a supine heart rate ≥ 100 beats per minute after 10 minutes of rest
  4. Patient has a troponin I at screening that is above the upper limit of normal
  5. The patient has severe aortic or mitral stenosis
  6. The patient has active myocarditis; clinically significant restrictive, constrictive, or hypertrophic obstructive cardiomyopathy; clinically significant congenital heart disease; history of major organ transplantation
  7. The patient has Canadian Cardiovascular Society Class IV angina
  8. Patient is on chronic anti-arrhythmic therapy, with the exception of amiodarone
  9. Patient has impaired renal function defined as an estimated GFR ≤ 30 ml/min/1.73 m2 calculated by the Modification of Diet in Renal Disease (MDRD) equation
  10. Patient is currently taking, or has taken within 14 days prior to enrollment, a potent CYP3A4 inhibitor (medication or food). Patient is currently taking, or has taken within 28 days prior to enrollment, a potent CYP3A4 inducer (medication or food).
  11. The patient has hepatic impairment defined as a total bilirubin > 3 mg/dL, or an ALT or AST > 2 times the upper limit of normal
  12. Concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 1 year
  13. The patient has received an investigational drug or device within 30 days or 5 half-lives, whichever is greater, of enrollment
  14. Patient has, in the opinion of the Investigator, a condition that compromises the ability of the subject to give written informed consent or to comply with study procedures, including scheduled self-administration of oral CK-1827452
  15. The patient has had any prior treatment with CK-1827452
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00941681
Other Study ID Numbers  ICMJE CY 1021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cytokinetics
Study Sponsor  ICMJE Cytokinetics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cytokinetics
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP