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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 September 2015
• Main ID: NCT02388464
• Date of registration: 01/03/2015
• Prospective Registration: No
• Primary sponsor: Stealth BioTherapeutics Inc.
• Public title: A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
• Scientific 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
• Date of first enrolment: July 2014
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02388464
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Bulgaria

Contacts

• Name: Jim Carr, PharmD
• Affiliation: Stealth BioTherapeutics Inc.

• Name: Sotir Marchev, MD,PhD, FESC
• Affiliation: Bulgaria

Key inclusion & exclusion criteria

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.



Age minimum: 45 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Congestive Heart Failure

Intervention(s)

Drug: Placebo

Drug: MTP-131

Primary Outcome(s)

Incidence of Adverse Events [Time Frame: Assessed up to Day 7]

Secondary Outcome(s)

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

Secondary ID(s)

SPIHF-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors