NCT01753115

Ciprofloxacin BioThrax Co-Administration Study

A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

Detailed description

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and BioThrax.

Conditions

• Anthrax

Interventions

Type	Name	Description
BIOLOGICAL	BioThrax	route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
DRUG	Ciprofloxacin	500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-12-20
• Last updated: 2025-06-15
• Results posted: 2014-11-19

Locations

3 sites across 1 country: United States