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

Sponsor

Stealth BioTherapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02388464

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Drug: MTP-131 Drug: MTP-131 Drug: MTP-131 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

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 :

Jul 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events [Assessed up to Day 7]

Secondary Outcome Measures

Left ventricular ejection fraction assessed by 2-D echocardiography [Assessed up to 24 hours post-infusion start]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stealth BioTherapeutics Inc.

ClinicalTrials.gov Identifier:

NCT02388464

Other Study ID Numbers:

SPIHF-101

First Posted:

Mar 17, 2015

Last Update Posted:

Sep 17, 2015

Last Verified:

Sep 1, 2015

Keywords provided by Stealth BioTherapeutics Inc.

Congestive Heart Failure

Bendavia™

MTP-131

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Sep 17, 2015