Healthy
Conditions
Keywords
Drug Safety, Clinical Trial, Phase I, Nontherapeutic Human Experimentation, Heading Pharmacokinetics, Phase I Safety and Tolerability
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.
Interventions
DRUGMTP-131 (Bendavia™)
Single 4 hour intravenous infusion
Sponsors
Stealth BioTherapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed