DRUG
MTP-131 (Bendavia™)
Single 4 hour intravenous infusion
Status
Completed
Phase
Phase 1
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study summary
This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.
The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.
Interventions
DRUG
Single 4 hour intravenous infusion
Timeline
First posted
May 4, 2010
Study start
May 2010
Primary completion
Sep 2010
Study completion
Sep 2010
Results posted
Not reported
Registry updated
Nov 18, 2010
Outcomes
Treatment emergent adverse events in treatment group versus placebo group
Time frame · 7 days
Safety assessments including vital signs, physical exam,12-lead ECG, serum chemistry, hematology, and urinalysis will be collected the day prior to and for 7 days following study drug infusion. These parameters will be assessed for clinically significant abnormalities.
Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality.
Time frame · Pre-infusion through 32 hours post infusion
Css (plasma steady state concentration), Cmax (observed peak plasma concentration), tmax (time of observed peak), AUC0-t (area under the plasma concentration time curve from time zero to the last quantifiable timepoint), AUC0-∞ (area under the plasma concentration time curve from time zero to infinity), λz (terminal \[or elimination rate\] phase rate constant), t½ (terminal half-life), CL (plasma clearance) and Vss (volume of distribution at steady state) will be determined for MTP-131. Ae (amount excreted in the urine) and CLr (renal clearance) may also be evaluated.
Eligibility
Inclusion Criteria: * Healthy adult males or females age ≥18 years of age with signed informed consent. * Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study. Exclusion Criteria: * Clinically significant laboratory abnormalities, * Clinically significant abnormalities on physical examination, * BMI of less than 18 kg/m2 or greater than 32 kg/m2, * Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems, * History of seizures or epilepsy, * History of serious mental illness, * Participant in unrelated research involving investigational product within 30 days before planned date of drug administration, * Positive serology for HIV 1, HIV 2, HBsAg, or HCV, * Fever greater than 37.5°C at the time of planned dosing, * Suspicion of or recent history of alcohol or substance abuse, * Donated blood or blood products within the past 30 days, * Women who are pregnant or breastfeeding, * Employee or family member of the investigational site, and * Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products, * Subjects who are either unwilling to agree to refrain from use or found to be using: 1. Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period 2. Prescription medications from 14 days prior to and 7 days post treatment 3. Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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