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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2015
• Main ID: NCT02388529
• Date of registration: 01/03/2015
• Prospective Registration: Yes
• Primary sponsor: Stealth BioTherapeutics Inc.
• Public title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02388529
• 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:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Drug: Placebo

Drug: MTP-131

Primary Outcome(s)

Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort [Time Frame: Assessed up to Day 12]

Incidence of Adverse Events [Time Frame: Assessed up to Day 33]

Secondary Outcome(s)

Changes in echocardiographic LV end-systolic volume (LVESV) [Time Frame: Assessed up to Day 33]

Secondary ID(s)

SPIHF-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors