MedTrace Logo

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

NCT01513200 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-04-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth C Lasseter, MD · Clinical Pharmacology of Miami

  • Richard Straube, MD · Stealth Peptides

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513200 on ClinicalTrials.gov