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Ph1 Study of Valortim and Ciprofloxacin in Humans

NCT00964561 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-08-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human subjects.

Conditions

  • Anthrax

Interventions

DRUG

Ciprofloxacin and Valortim

Days 1-3 400mg IV Ciprofloxacin BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.

DRUG

Placebo Antibiotic and Valortim

Days 1-3 20mg/kg IV Normal Saline BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.

OTHER

Placebo Antibiotic and Placebo Valortim

Days 1-3 200mL IV Normal Saline for Placebo Antibiotic over 60 minutes. Day 4 200mL IV Normal Saline for Placebo Valortim over 60 minutes.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Medarex

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Department of Health and Human Services

    collaborator FED

  • PharmAthene, Inc.

    lead INDUSTRY

Principal Investigators

  • Ralph A. Schutz, M.D. · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-02-28
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00964561 on ClinicalTrials.gov