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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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ClinicalTrials.gov Identifier: NCT02388464
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

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).

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: MTP-131 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Low dose Drug: MTP-131
MTP-131 (low dose) administered as single intravenous infusion over 4 hours

Experimental: Intermediate dose Drug: MTP-131
MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours

Experimental: High dose Drug: MTP-131
MTP-131 (high dose) administered as single intravenous infusion over 4 hours

Experimental: Placebo Drug: Placebo
Placebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Assessed up to Day 7 ]

Secondary Outcome Measures :
  1. Left ventricular ejection fraction assessed by 2-D echocardiography [ Time Frame: Assessed up to 24 hours post-infusion start ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388464


Locations
Bulgaria
Sevlievo, Gabrovo, Bulgaria
Sponsors and Collaborators
Stealth BioTherapeutics Inc.
Investigators
Study Director: Jim Carr, PharmD Stealth BioTherapeutics Inc.
Principal Investigator: Sotir Marchev, MD,PhD, FESC Bulgaria

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stealth BioTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT02388464     History of Changes
Other Study ID Numbers: SPIHF-101
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

Keywords provided by Stealth BioTherapeutics Inc.:
Congestive Heart Failure
Bendavia™
MTP-131

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases