ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02388529
Recruitment Status : Withdrawn
First Posted : March 17, 2015
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: MTP-131 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Low dose Drug: MTP-131
MTP-131 (low dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days

Experimental: Intermediate dose Drug: MTP-131
MTP-131 (intermediate dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days

Experimental: High dose Drug: MTP-131
MTP-131 (high dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days

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




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Assessed up to Day 33 ]
  2. Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort [ Time Frame: Assessed up to Day 12 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388529


Locations
Bulgaria
Sevlievo, Gabrovo, Bulgaria
Sponsors and Collaborators
Stealth BioTherapeutics Inc.
Investigators
Study Director: Jim Carr, PharmD Stealth BioTherapeutics Inc.
Principal Investigator: Sotir Marchev, MD,PhD, FESC Bulgaria

Responsible Party: Stealth BioTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT02388529     History of Changes
Other Study ID Numbers: SPIHF-202
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by Stealth BioTherapeutics Inc.:
Heart Failure
Bendavia™
MTP-131

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases