Clinical trial NCT01115920: Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults
Official title: A Phase I Study in Healthy Male and Healthy Female Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MTP-131 (Bendavia™) Using a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug Safety
Clinical Trial, Phase I
Nontherapeutic Human Experimentation
Heading Pharmacokinetics
Phase I Safety and Tolerability
Lead sponsor: Stealth BioTherapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment emergent adverse events in treatment group versus placebo group
timeFrame: 7 days
Secondary outcomes:
measure: Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality.
timeFrame: Pre-infusion through 32 hours post infusion
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
Study officials:
affiliation: Clinical Pharmacology of Miami, Inc.
name: Kenneth Lasseter, MD
role: PRINCIPAL_INVESTIGATOR
References: