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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: | NCT00964834 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV doxycycline when administered concomitantly with IV Valortim in normal healthy human subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Anthrax |
Drug: Doxycycline and Valortim Drug: Placebo Antibiotic and Valortim Drug: 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) Doxycycline in Healthy Normal Subjects |
| Estimated Enrollment: | 24 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Doxycycline and Valortim: Experimental
Randomized such that sixteen volunteer subjects to be renadomized to receive Doxycycline and Valortim
|
Drug: Doxycycline and Valortim
Days 1-5 100mg IV Doxycycline BID over 60 minutes. Day 6 20mg/kg Valortim IV over 60 minutes.
|
|
Placebo Antibiotic and Valortim: Experimental
Randomized such that four volunteer subjects to receive Placebo Antibiotic and Valortim.
|
Drug: Placebo Antibiotic and Valortim
Days 1-5 20mg/kg IV Normal Saline BID over 60 minutes. Day 6 20mg/kg IV Valortim over 60 minutes.
|
|
Placebo Antibiotic and Placebo Valortim: Experimental
Randomized such that four volunteer subjects to receive Placebo Antibiotic and Placebo Valortim.
|
Drug: Placebo Antibiotic and Placebo Valortim
Days 1-5 200mL IV Normal Saline for Placebo Antibiotic BID over 60 minutes. Day 6 20mg/kg 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 Bacillus 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 symptoms of inhalational anthrax. Because the treatment of inhalational anthrax includes the use of antibiotics such as tetracyclines, 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 pharmacokinetics of doxycycline (a commonly used tetracycline 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 65 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 christy.stimac@quintiles.com | |
| Principal Investigator: David Mathews, M.D. | |
| Sub-Investigator: Philip Leese, M.D. | |
| Sub-Investigator: Ralph Schutz, 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: | Daivd Mathews, M.D. | Quintiles |
More Information
| Responsible Party: | PharmAthene, Inc. ( Valerie Riddle, M.D., Vice President and Medical Director ) |
| Study ID Numbers: | #0036-08-06, NIAID #08-0054 |
| Study First Received: | August 24, 2009 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00964834 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bacterial Infections Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents Antiprotozoal Agents |
Gram-Positive Bacterial Infections Therapeutic Uses Bacillaceae Infections Anthrax Pharmacologic Actions Doxycycline |