Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults
- Conditions
- Healthy
- Interventions
- Drug: MTP-131 (Bendavia™)
- Registration Number
- NCT01115920
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
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Clinically significant laboratory abnormalities,
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Clinically significant abnormalities on physical examination,
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BMI of less than 18 kg/m2 or greater than 32 kg/m2,
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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,
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History of seizures or epilepsy,
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History of serious mental illness,
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Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,
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Positive serology for HIV 1, HIV 2, HBsAg, or HCV,
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Fever greater than 37.5°C at the time of planned dosing,
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Suspicion of or recent history of alcohol or substance abuse,
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Donated blood or blood products within the past 30 days,
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Women who are pregnant or breastfeeding,
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Employee or family member of the investigational site, and
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Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,
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Subjects who are either unwilling to agree to refrain from use or found to be using:
- 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
- Prescription medications from 14 days prior to and 7 days post treatment
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 MTP-131 (Bendavia™) Cohort 1, Dose 0.010 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Arm 2 MTP-131 (Bendavia™) Cohort 2, Dose 0.025 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Arm 3 MTP-131 (Bendavia™) Cohort 3, Dose 0.050 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Arm 4 MTP-131 (Bendavia™) Cohort 4, Dose 0.100 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Arm 5 MTP-131 (Bendavia™) Cohort 5, Dose 0.250 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)
- Primary Outcome Measures
Name Time Method Treatment emergent adverse events in treatment group versus placebo group 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.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality. 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.
Trial Locations
- Locations (1)
Clinical Pharmacology of Miami, Inc.
🇺🇸Miami, Florida, United States