The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.

Key facts

Study ID

NCT01518985

Run by

Stealth BioTherapeutics Inc.

People needed

6

Starts

2012-01-01

Expected to finish

2012-03-01

Last updated by the study team

2012-04-19

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult male smokers between 18 and 65 years of age with signed informed consent

You may not qualify if…

• Serum sodium level below the lower limit of sites' clinical laboratory normal range at screening, D-1 and 6
• Cholesterol level ≥ 240 mg/dL
• Hypertension (blood pressure SBP > 140, DBP > 90 mmHg)
• Body mass index < 18 or > 32 kg/m2,
• Creatinine clearance calculated by the Cockcroft and Gault method calculated to be < 90 mL/min,
• Additional laboratory abnormalities determined as clinically significant by the Principal Investigator at laboratory screening
• Clinically significant abnormalities on physical examination,
• History or evidence of renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) system dysfunction,
• History of seizures or history of epilepsy,
• History of serious (Principal Investigator judgment) mental illness,
• Receipt of investigational medicinal product within 30 days prior to the planned date of study drug administration,
• Positive serology for human immunodeficiency virus type 1 or 2, or hepatitis B surface antigen,
• Fever > 37.5°C at the time of planned dosing,
• Suspicion, or recent history, of alcohol or substance abuse,
• Donated blood or blood products within the past 30 days,
• Employee or family member of the investigational site,
• Subjects who are either unwilling to agree to refrain from use or found to be using Nicotine (or nicotine products) including cigarettes from 12 hours prior to start of each study drug infusion through to the completion of endothelial function testing, Alcohol, Caffeine, Xanthine-containing food or beverages and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement periods, Supplementary antioxidant vitamins from 7 days prior to dosing and throughout the confinement periods, Prescription medications from 14 days prior to and 7 days post treatment
• Subjects having previous exposure to Bendavia.

Where it is running

• Clinical Pharmaology of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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