NCT01513200

Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia

A Two Part Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers and the Effects of Bendavia™ and Unfractionated Heparin When Administered Concurrently

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stealth BioTherapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Unfractionated heparin (UFH)	UFH solution for infusion Initially 60U/kg bolus followed by intravenous infusion (12U/kg/hr) for approximately 11 hours
DRUG	Bendavia	Bendavia for infusion Constant intravenous infusion (Bendavia 0.25mg/kg/hr) for 4 hours
DRUG	Saline (0.9%, sterile, for infusion)	Saline (placebo) Constant IV infusion for 4 hours

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-01-20
• Last updated: 2012-04-19

Locations

1 site across 1 country: United States