Heart FailurePhase 2NCT01077167
Pharmacokinetic Study of Omecamtiv Mecarbil in Heart Failure Patients
A Phase 2 study testing Omecamtiv mecarbil in people with Heart Failure, run by Cytokinetics.
Trial summary
The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the blood over time) of Omecamtiv mecarbil in patients with stable heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Omecamtiv mecarbil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- ≥18 years old at the time of consent
- Heart failure (HF) for ≥ 3 months and New York Heart Association class II or III at enrollment
- Left ventricular ejection fraction < / = 35% by most recent echocardiogram within 3 months of enrollment. For patients with cardiac resynchronization therapy (CRT), left ventricular ejection fraction (LVEF) assessment for eligibility must be performed at least 3 months after device implantation
- Treated for HF with optimal, stable pharmacological therapy. In general, optimal treatment will include a beta-blocker and an Angiotensin Converting Enzyme (ACE) inhibitor and/or an Angiotensin Receptor Blocker (ARB) at doses shown to be efficacious in Heart Failure (HF) trials, unless not tolerated. Stable medical therapy is defined as having no new HF drug class introduced 4 weeks prior to enrollment, although doses of all drugs may be adjusted throughout the trial
- Considered to be an appropriate candidate for study enrollment as determined by the patient's clinical laboratory findings, vital signs and electrocardiograms (ECGs) within normal range, or if outside of the normal range not deemed clinically significant in the opinion of the Investigator
- 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 within 1 week following the last dose of omecamtiv mecarbil, and she is using highly effective methods of birth control. Postmenopausal female is defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40mIU/mL, or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)
- For male patients only: Male patients agree for the duration of the study and 11 weeks after the last dose of omecamtiv mecarbil 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 the duration of the study and 11 weeks after the last dose of omecamtiv mecarbil.
Who cannot join
- HF hospitalization, acute coronary syndrome, myocardial infarction, percutaneous intervention coronary revascularization, transient ischemic attack or stroke, cardiac arrhythmia within 6 weeks prior to enrollment , or major surgery including thoracic or cardiac within 8 weeks prior to enrollment
- Symptoms of angina at rest or with minimal activity (Canadian Cardiovascular Society class III and IV)
- Severe aortic or mitral stenosis or clinically significant valvular heart disease that might lead to surgical correction within 12 months of enrollment
- Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
- Refractory, end-stage, heart failure defined as subjects who are appropriate candidates in the opinion of the investigator for ventricular assist devices, continuous inotropic therapy, or hospice care
- CRT implantation within 3 months or implantable cardioverter defibrillator (ICD) within 4 weeks prior to enrollment
Show all 24Show fewer
- Likely to receive cardiac transplant within 6 months after enrollment
- Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)
- Known to be hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) positive, or a known diagnosis of acquired immunodeficiency syndrome
- Recent (within 3 months) history of alcohol or illicit drug abuse
- Concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 1 year
- Routinely scheduled outpatient intravenous (IV) infusions for HF (eg, inotropes, vasodilators [eg, nesiritide], diuretics) or routinely scheduled ultrafiltration
- Subjects on digoxin therapy with a steady state plasma level (approximately 6 hours post-dose) that exceeds 1.0 ng/mL at screening
- Chronic antiarrhythmic therapy, with the exception of amiodarone
- Currently taking, or has taken within 14 days prior to enrollment, a potent Cytochrome P450 3A4 (CYP3A4) inhibitor
- Currently taking, or has taken within 28 days prior to enrollment, a potent CYP3A4 inducer
- Prior treatment with omecamtiv mecarbil
- Currently enrolled in, or at least 60 days or 5 half-lives, whichever is greater, since ending participation in other investigational device or drug trial(s) or receiving other investigational agent
- Systolic blood pressure > 150 mm Hg or < 80 mm Hg, or diastolic blood pressure > 95 mm Hg, assessed on two separate occasions prior to enrollment
- Supine heart rate ≥ 100 beats per minute after 5 minutes of rest or an untreated symptomatic bradyarrhythmia within 1 month prior to enrollment
- Troponin I at screening > upper limit of normal (ULN)
- Total bilirubin ≥ 1.5 times ULN, or an Alanine transaminase (ALT) or Aspartate transaminase (AST) ≥ 3 times ULN
- Estimated glomerular filtration rate (GFR) ≤ 30 ml/min/1.73 m2 calculated by the Modification of Diet in Renal Disease (MDRD) equation
- 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
About this study
Official title: An Open Label, Multiple Dose Study to Investigate the Pharmacokinetics of Omecamtiv Mecarbil Administered Orally to Patients With Stable Heart Failure
The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the blood over time) of Omecamtiv mecarbil in patients with stable heart failure.
Read the detailed description
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.
- Conditions
- Heart Failure
- Being tested
- Omecamtiv mecarbil
- Keywords
- Omecamtiv mecarbil, pharmacokinetics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omecamtiv mecarbilDrug
Also called AMG 423
Oral dosing twice each day or three times each day, depending on the cohort assignment, of Omecamtiv mecarbil for 8 days. Omecamtiv mecarbil comes in 2 formulations: modified release and immediate release, and the formulation given will depend on the cohort assignment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Omecamtiv mecarbil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of oral formulations of Omecamtiv mecarbil following the morning dose on Days 7 and 8
Measured: Following 8 Days of dosing
Secondary outcomes (1)
Safety and tolerability of oral formulations of Omecamtiv mecarbil at steady state
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2011
- Study completionMay 2011 (estimated)
Why it stopped: Study cancelled due to sponsor's decision to redesign the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytokinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077167
- Sponsor's protocol ID
- 20090618
- Status last verified
- Jul 2021
- First submitted
- 25 Feb 2010
- Last updated
- 30 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multiple Dose Study to Investigate the Pharmacokinetics of Omecamtiv Mecarbil Administered Orally to Patients With Stable Heart Failure
- ClinicalTrials.gov ID
- NCT01077167
- Acronym / sponsor ID
- 20090618
- Conditions
- Heart Failure
- Keywords
- Omecamtiv mecarbil, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled due to sponsor's decision to redesign the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (estimated)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the blood over time) of Omecamtiv mecarbil in patients with stable heart failure.
Detailed description
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Omecamtiv mecarbil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- ≥18 years old at the time of consent
- Heart failure (HF) for ≥ 3 months and New York Heart Association class II or III at enrollment
- Left ventricular ejection fraction < / = 35% by most recent echocardiogram within 3 months of enrollment. For patients with cardiac resynchronization therapy (CRT), left ventricular ejection fraction (LVEF) assessment for eligibility must be performed at least 3 months after device implantation
- Treated for HF with optimal, stable pharmacological therapy. In general, optimal treatment will include a beta-blocker and an Angiotensin Converting Enzyme (ACE) inhibitor and/or an Angiotensin Receptor Blocker (ARB) at doses shown to be efficacious in Heart Failure (HF) trials, unless not tolerated. Stable medical therapy is defined as having no new HF drug class introduced 4 weeks prior to enrollment, although doses of all drugs may be adjusted throughout the trial
Key exclusion criteria (24 listed)
- HF hospitalization, acute coronary syndrome, myocardial infarction, percutaneous intervention coronary revascularization, transient ischemic attack or stroke, cardiac arrhythmia within 6 weeks prior to enrollment , or major surgery including thoracic or cardiac within 8 weeks prior to enrollment
- Symptoms of angina at rest or with minimal activity (Canadian Cardiovascular Society class III and IV)
- Severe aortic or mitral stenosis or clinically significant valvular heart disease that might lead to surgical correction within 12 months of enrollment
- Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
- Refractory, end-stage, heart failure defined as subjects who are appropriate candidates in the opinion of the investigator for ventricular assist devices, continuous inotropic therapy, or hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omecamtiv mecarbilAlso: AMG 423Oral dosing twice each day or three times each day, depending on the cohort assignment, of Omecamtiv mecarbil for 8 days. Omecamtiv mecarbil comes in 2 formulations: modified release and immediate release, and the formulation given will depend on the cohort assignment. | Drug | 1 |
Primary outcome
Pharmacokinetic profile of oral formulations of Omecamtiv mecarbil following the morning dose on Days 7 and 8
Time frame: Following 8 Days of dosing
1 secondary outcome
Safety and tolerability of oral formulations of Omecamtiv mecarbil at steady state
Time frame: 14 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omecamtiv mecarbil in people with Heart Failure, run by Cytokinetics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of oral formulations of Omecamtiv mecarbil following the morning dose on Days 7 and 8 (time frame: Following 8 Days of dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.