Current partner codePEPTIDESDE
NCT02388464·Phase 1·INTERVENTIONAL

A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

Status

Completed

Phase

Phase 1

Enrollment

36

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

MTP-131

MTP-131 (low dose) administered as single intravenous infusion over 4 hours

DRUG

MTP-131

MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours

DRUG

MTP-131

MTP-131 (high dose) administered as single intravenous infusion over 4 hours

DRUG

Placebo

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

Timeline

From registration to results.

  1. First posted

    Mar 17, 2015

  2. Study start

    Jul 2014

  3. Primary completion

    Apr 2015

  4. Study completion

    Jun 2015

  5. Results posted

    Not reported

  6. Registry updated

    Sep 17, 2015

Outcomes

What the study measures.

Primary outcomes

Incidence of Adverse Events

Time frame · Assessed up to Day 7

Secondary outcomes

Left ventricular ejection fraction assessed by 2-D echocardiography

Time frame · Assessed up to 24 hours post-infusion start

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

Bulgaria. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Sevlievo, Gabrovo, Bulgaria

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Put the record in context.

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