A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure

NCT02388529 | Withdrawn Phase 1 DMC

• 1 other identifier: SPIHF-202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, randomized, double-blind, placebo-controlled study in patients with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.

Conditions

Heart Failure

Keywords

Heart Failure; Bendavia™; MTP-131

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  Assessed up to Day 33

• Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort

  Assessed up to Day 12

Secondary Outcomes (1)

• Changes in echocardiographic LV end-systolic volume (LVESV)

  Assessed up to Day 33

Study Arms (4)

Low dose

EXPERIMENTAL

Drug: MTP-131

Intermediate dose

EXPERIMENTAL

Drug: MTP-131

High dose

EXPERIMENTAL

Drug: MTP-131

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MTP-131 DRUG

MTP-131 (low dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days

Low dose

Placebo DRUG

Placebo Comparator (at each dose cohort) administered as once-daily 1- hour intravenous infusion for 5 consecutive days

Placebo

Eligibility Criteria

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

You may qualify if:

• LVEF ≤45% by 2-D echocardiogram.
• Diagnosis of New York Heart Association Class II or III HF for a minimum of 6 months prior to the Screening Visit.
• HF is considered to be stable, in the judgment of the Principal Investigator and no hospitalization related to HF has occurred within the 1 month 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
• Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit.
• Written informed consent obtained that strictly adheres to the written guidelines from the local Ethical Committee (EC).

You may not qualify if:

• 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.
• Supine resting heart rate ≥ 100 beats per minute after 5 minutes rest.
• 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 (e.g., pericardectomy).
• Cardiac surgery or valvuloplasty within 2 month 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.
• Liver enzyme (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) elevation \>3x the upper limit of normal (ULN).
• Estimated glomerular filtration rate (eGFR) \<30 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation.
• Known active drug or alcohol abuse.
• Active infection requiring systemic treatment or surgical intervention.
• Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Sponsors & Collaborators

• Stealth BioTherapeutics Inc.: lead

Study Sites (1)

Unknown Facility

Sevlievo, Gabrovo, Bulgaria

Location

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: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

BU (1)