Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01115920

Run by

Stealth BioTherapeutics Inc.

People needed

40

Starts

2010-05-01

Expected to finish

2010-09-01

Last updated by the study team

2010-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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

Where it is running

• Clinical Pharmacology of Miami, Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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