Status:
COMPLETED
The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking
Lead Sponsor:
Stealth BioTherapeutics Inc.
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
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 ind...
Eligibility Criteria
Inclusion
- \- Healthy adult male smokers between 18 and 65 years of age with signed informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01518985
Start Date
January 1 2012
End Date
March 1 2012
Last Update
April 19 2012
Active Locations (1)
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1
Clinical Pharmaology of Miami
Miami, Florida, United States, 33014-3616