NCT01518985

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

A Phase 1, Placebo-Controlled Trial to Evaluate the Impact of Intravenous (IV) Bendavia™ (MTP-131) on Endothelial Reactivity Dysfunction Induced by Cigarette Smoking

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Stealth BioTherapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Bendavia	Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours
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

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-01-26
• Last updated: 2012-04-19

Locations

1 site across 1 country: United States