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

NCT02388464 | Completed Phase 1 DMC

• 1 other identifier: SPIHF-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Bendavia™; MTP-131

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Assessed up to Day 7

Secondary Outcomes (1)

• Left ventricular ejection fraction assessed by 2-D echocardiography

  Assessed up to 24 hours post-infusion start

Study Arms (4)

Low dose

EXPERIMENTAL

Drug: MTP-131

Intermediate dose

EXPERIMENTAL

Drug: MTP-131

High dose

EXPERIMENTAL

Drug: MTP-131

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

MTP-131 DRUG

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

Low dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stealth BioTherapeutics Inc.: lead

Study Sites (1)

Unknown Facility

Sevlievo, Gabrovo, Bulgaria

Location

Related Publications (1)

• 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.

  PMID: 29217757 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jim Carr, PharmD

  Stealth BioTherapeutics Inc.

  STUDY DIRECTOR

• Sotir Marchev, MD,PhD, FESC

  Bulgaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 17, 2015
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

BU (1)