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

NCT ID: NCT01518985

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-03-31

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 induced by a single cigarette.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Intravenous infusion of saline (0.9%) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start

Group Type: PLACEBO_COMPARATOR

Sterile saline (0.9%)

Intervention Type: DRUG

Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours

Cigarette smoking

Intervention Type: OTHER

One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.

Bendavia

Intravenous infusion of Bendavia (0.25mg/kg/hr) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start

Group Type: EXPERIMENTAL

Bendavia

Intervention Type: DRUG

Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours

Cigarette smoking

Intervention Type: OTHER

One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.

Interventions

Bendavia

Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours

Intervention Type: DRUG

Sterile saline (0.9%)

Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours

Intervention Type: DRUG

Cigarette smoking

One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stealth BioTherapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth C Lasseter, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology of Miami

Richard Straube, MD

Role: STUDY_DIRECTOR

Stealth Peptides

Locations

Clinical Pharmaology of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

SPIRI-120

Identifier Type: -

Identifier Source: org_study_id