The Impact of Intravenous Bendavia™ on Endothelial Reacti... | NCT01518985

NCT01518985

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Intravenous infusion of saline (0.9%) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start	Drug: Sterile saline (0.9%) Other: Cigarette smoking
Bendavia	Experimental	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	Drug: Bendavia Other: Cigarette smoking

Name	Type	Description	Arm Group Labels	Other Names
Bendavia	Drug	Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours	Bendavia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia	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.	Baseline, +30, +60, +90 minutes post-study-drug administration start

Secondary Outcomes

Measure	Description	Time Frame
Anova between group mean inflammatory laboratory marker (hs-CRP; mg/L) after smoking one cigarette with and without Bendavia	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.	Baseline to 24 hours post-study-drug administration

Eligibility Module

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.

Name	Affiliation	Role
Kenneth C Lasseter, MD	Clinical Pharmacology of Miami	Principal Investigator
Richard Straube, MD	Stealth Peptides	Study Director