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

Heart Failure Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Due to Reduced Left Ventricular Ejection Fraction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02388529
• Other study ID #: SPIHF-202
• Status: Withdrawn
• Phase: Phase 1
• First received: March 1, 2015
• Last updated: October 14, 2015
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Stealth BioTherapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

• Female patients who are pregnant or breastfeeding.

• Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• MTP-131
MTP-131 (low dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
• MTP-131
MTP-131 (intermediate dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
• MTP-131
MTP-131 (high dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
• Placebo
Placebo Comparator (at each dose cohort) administered as once-daily 1- hour intravenous infusion for 5 consecutive days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stealth BioTherapeutics Inc.

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events		Assessed up to Day 33	Yes
Primary	Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort		Assessed up to Day 12	No
Secondary	Changes in echocardiographic LV end-systolic volume (LVESV)		Assessed up to Day 33	No