DRUG
Bendavia
Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours
The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking
Status
Completed
Phase
Phase 1
Enrollment
6
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Sterile saline (0.9%)
Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours
OTHER
Cigarette smoking
One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.
Timeline
From registration to results.
First posted
Jan 26, 2012
Study start
Jan 2012
Primary completion
Mar 2012
Study completion
Mar 2012
Results posted
Not reported
Registry updated
Apr 19, 2012
Outcomes
What the study measures.
Primary outcomes
Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia
Time frame · Baseline, +30, +60, +90 minutes post-study-drug administration start
Endothelial function will be determined using EndoPAT 2000 (Itamar Medical Ltd) prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of endothelial function (EndoPAT Index) between placebo and active study drug within a subject will be performed. EndoPAT quantifies the endothelium-mediated changes in vascular tone. A post-occlusion to pre-occlusion ratio is calculated providing the EndoPAT index.
Secondary outcomes
Anova between group mean inflammatory laboratory marker (hs-CRP; mg/L) after smoking one cigarette with and without Bendavia
Time frame · Baseline to 24 hours post-study-drug administration
hs-CRP will be evaluated prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of hs-CRP levels between placebo and active study drug within a subject will be performed.
ANOVA between group means of urinary 8-isoprostane (ng/mg of creatinine) after smoking one cigarette with and without Bendavia
Time frame · Baseline to 48 hours post-study-drug administration
8-isoprostane will be measured prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of laboratory results between placebo and active study drug within a subject will be performed.
Number adverse events with and without Bendavia
Time frame · Baseline to Study Day 10
Adverse events will be tabulated by treatment group. No statistical analysis will be preformed.
Assessment of Bendavia exposure measured by area Under the Curve (AUC; ng*hr/mL)
Time frame · Baseline to 48 hours post-study-drug administration
Bendavia levels will be measured and pharmacokinetic parameters reported.
ANOVA between group means of urinary 8-hydroxy-2'-deoxyguanosine (pg/mL) after smoking one cigarette with and without Bendavia
Time frame · Baseline to 48 hours post-study-drug administration
8-hydroxy-2'-deoxyguanosine will be measured prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of laboratory results between placebo and active study drug within a subject will be performed.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- MALE
- Healthy volunteers
- Yes
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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Clinical Pharmaology of Miami
Miami, Florida, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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