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| Sponsor: | PharmAthene, Inc. |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) Medarex Quintiles Biomedical Advanced Research and Development Authority (BARDA) |
| Information provided by: | PharmAthene, Inc. |
| ClinicalTrials.gov Identifier: | NCT00964561 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anthrax |
Drug: Ciprofloxacin and Valortim Drug: Placebo Antibiotic and Valortim Other: Placebo Antibiotic and Placebo Valortim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A Phase I, Single Blind, Randomized, Placebo Controlled, Drug Interaction Study of Intravenous (IV) Valortim® and Intravenous (IV) Ciprofloxacin in Healthy, Normal Subjects |
| Estimated Enrollment: | 26 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Ciprofloxacin and Valortim: Experimental
First two subjects to receive treatment arm of Ciprofloxacin and Valortim. Total of sixteen volunteers to be randomized to receive Ciprofloxacin and Valortim.
|
Drug: Ciprofloxacin and Valortim
Days 1-3 400mg IV Ciprofloxacin BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.
|
|
Placebo Antibiotic and Valortim: Experimental
Randomized such that four subjects to receive Placebo Antibiotic and Valortim.
|
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.
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Placebo Antibiotic and Placebo Valortim: Experimental
Randomized such that 4 subjects to receive Placebo Antibiotic and Placebo Valortim.
|
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.
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Valortim (MDX-1303) is a fully human monoclonal antibody (hmAb) with a high affinity for B. anthracis protective antigen (PA). Valortim is designed to target PA, which is one of three plasmid-encoded proteins that together form the toxins released by B. anthracis. Individually, these proteins (protective antigen (PA), lethal factor (LF) and edema factor (EF)) are inactive. Toxic effects require the transport of LF and EF into the host cell, mediated by the activity of PA. Valortim binds to PA and interferes with the activity of the toxins. Based on both non-clinical and clinical data, Valortim may have utility for the pre- and post-exposure prophylaxis of individuals exposed to, or at risk of exposure to, B. anthracis and for the treatment of individuals displaying signs or symptoms of inhalational anthrax. Because the treatment of inhalational anthrax includes the use of antibiotics such as fluoroquinolones, it is necessary to demonstrate that there are no adverse interactions between newer therapeutic interventions and these medications. The purpose of this study is to assess the safety and pharmacokinetics of ciprofloxacin (a commonly used fluoroquinolone for both treatment and post-exposure prophylaxis of anthrax) and Valortim following co-administration, as well as the safety and tolerability of these medications when administered concomitantly. These data are intended to support the use of Valortim as a treatment for inhalational anthrax.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women of childbearing potential may be enrolled if one of the following criteria applies:
Sexually active male subjects may be enrolled if one of the following criteria applies:
Exclusion Criteria:
Contacts and Locations| United States, Kansas | |
| Quintiles Phase I Services | Recruiting |
| Overland Park, Kansas, United States, 66211 | |
| Contact: Christy Stimac 913-894-5533 | |
| Principal Investigator: Ralph A. Schutz, M.D. | |
| Sub-Investigator: Philip Leese, M.D. | |
| Sub-Investigator: David Mathews, M.D. | |
| Sub-Investigator: Eleanor Lisbon, M.D. | |
| Sub-Investigator: Kelli Craven, M.D. | |
| Sub-Investigator: Patricia Meier, M.D. | |
| Sub-Investigator: William L. Newland, M.D. | |
| Principal Investigator: | Ralph A. Schutz, M.D. | Quintiles |
More Information
| Responsible Party: | PharmAthene, Inc. ( Valerie Riddle, M.D., Vice President and Medical Director ) |
| Study ID Numbers: | #0036-08-05, NIAID #08-0053 |
| Study First Received: | August 22, 2009 |
| Last Updated: | August 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00964561 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bacterial Infections Anti-Infective Agents Ciprofloxacin Anti-Bacterial Agents Gram-Positive Bacterial Infections Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Bacillaceae Infections Anthrax Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |