A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
Bulgaria
Study Type
Interventional
Intervention
MTP-131
MTP-131
MTP-131
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Bendavia™, MTP-131
Eligibility Criteria
Inclusion Criteria:
- Chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis.
- LVEF ≤35% by 2-D echocardiogram.
- Diagnosis of NYHA Class II or III HF for a minimum of 6 months prior to the Screening Visit.
- HF is considered to be stable and no hospitalization for HF has occurred within the previous 3 months prior to the Screening visit.
- Treatment with appropriate pharmacologic therapy for HF including, but not limited to, angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB), and an evidence-based beta blocker for the treatment of HF (i.e. carvedilol, bisoprolol, or extended-release metoprolol).
- Dose and dose regimen of pharmacologic treatments for HF must be stable for a minimum of 1 month prior to the Screening Visit.
- Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and Day 1.
Exclusion Criteria:
- LV end-diastolic dimension (LVEDD), by the same method as qualifying LVEF, is >80 mm or LVEDD indexed to body surface area is >0.45.
- Unstable angina pectoris within 1 month before initiation of screening procedures. Unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (e.g., nitroglycerin).
- Coronary or peripheral artery revascularization procedure within 2 months prior to the Screening Visit.
- An acute myocardial infarction within 3 months prior to the Screening Visit.
- Placement of an automated implantable cardioverter defibrillator (AICD) or any hardware associated with resynchronization therapy.
- Atrial fibrillation at the Screening or Baseline Visits.
- Uncontrolled hypertension defined as a systolic blood pressure (BP) > 180 mm Hg or a diastolic BP >110 mm Hg on at least 2 consecutive readings.
- Requirement for valve or other cardiac surgery
- Cardiac surgery or valvuloplasty within 2 months prior to the Screening Visit.
- General surgery within 1 month prior to the Screening Visit
- Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic left ventricular aneurysm.
- Cerebrovascular accident or transient ischemic attack within 3 months prior to the Screening Visit.
- Estimated glomerular filtration rate (eGFR) <40 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation
- Serologic evidence of hepatitis B or C infection.
Known acquired immunodeficiency syndrome or HIV-positive status, or diagnosis of immunodeficiency.
- Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Low dose
Intermediate dose
High dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Secondary Outcome Measures
Left ventricular ejection fraction assessed by 2-D echocardiography
Full Information
NCT ID
NCT02388464
First Posted
March 1, 2015
Last Updated
September 16, 2015
Sponsor
Stealth BioTherapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02388464
Brief Title
A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
Official Title
A Phase 1 Clinical Pharmacology Study of the Effects of a Single 4 Hour Intravenous Infusion of Bendavia™ (MTP-131) in Subjects With Stable New York Heart Association Class II-III Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stealth BioTherapeutics Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive Heart Failure, Bendavia™, MTP-131
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Title
Intermediate dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MTP-131
Intervention Description
MTP-131 (low dose) administered as single intravenous infusion over 4 hours
Intervention Type
Drug
Intervention Name(s)
MTP-131
Intervention Description
MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours
Intervention Type
Drug
Intervention Name(s)
MTP-131
Intervention Description
MTP-131 (high dose) administered as single intravenous infusion over 4 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Time Frame
Assessed up to Day 7
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction assessed by 2-D echocardiography
Time Frame
Assessed up to 24 hours post-infusion start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis.
LVEF ≤35% by 2-D echocardiogram.
Diagnosis of NYHA Class II or III HF for a minimum of 6 months prior to the Screening Visit.
HF is considered to be stable and no hospitalization for HF has occurred within the previous 3 months prior to the Screening visit.
Treatment with appropriate pharmacologic therapy for HF including, but not limited to, angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB), and an evidence-based beta blocker for the treatment of HF (i.e. carvedilol, bisoprolol, or extended-release metoprolol).
Dose and dose regimen of pharmacologic treatments for HF must be stable for a minimum of 1 month prior to the Screening Visit.
Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and Day 1.
Exclusion Criteria:
LV end-diastolic dimension (LVEDD), by the same method as qualifying LVEF, is >80 mm or LVEDD indexed to body surface area is >0.45.
Unstable angina pectoris within 1 month before initiation of screening procedures. Unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (e.g., nitroglycerin).
Coronary or peripheral artery revascularization procedure within 2 months prior to the Screening Visit.
An acute myocardial infarction within 3 months prior to the Screening Visit.
Placement of an automated implantable cardioverter defibrillator (AICD) or any hardware associated with resynchronization therapy.
Atrial fibrillation at the Screening or Baseline Visits.
Uncontrolled hypertension defined as a systolic blood pressure (BP) > 180 mm Hg or a diastolic BP >110 mm Hg on at least 2 consecutive readings.
Requirement for valve or other cardiac surgery
Cardiac surgery or valvuloplasty within 2 months prior to the Screening Visit.
General surgery within 1 month prior to the Screening Visit
Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic left ventricular aneurysm.
Cerebrovascular accident or transient ischemic attack within 3 months prior to the Screening Visit.
Estimated glomerular filtration rate (eGFR) <40 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation
Serologic evidence of hepatitis B or C infection.
Known acquired immunodeficiency syndrome or HIV-positive status, or diagnosis of immunodeficiency.
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Carr, PharmD
Organizational Affiliation
Stealth BioTherapeutics Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sotir Marchev, MD,PhD, FESC
Organizational Affiliation
Bulgaria
Official's Role
Principal Investigator
Facility Information:
City
Sevlievo
State/Province
Gabrovo
Country
Bulgaria
12. IPD Sharing Statement
Citations:
PubMed Identifier
29217757
Citation
Daubert MA, Yow E, Dunn G, Marchev S, Barnhart H, Douglas PS, O'Connor C, Goldstein S, Udelson JE, Sabbah HN. Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide. Circ Heart Fail. 2017 Dec;10(12):e004389. doi: 10.1161/CIRCHEARTFAILURE.117.004389.
Results Reference
derived
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A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
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