Ph1 Study of Valortim and Ciprofloxacin in Humans
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|ClinicalTrials.gov Identifier: NCT00964561|
Recruitment Status : Suspended (On partial hold for clinical investigation into AE and SAE reported.)
First Posted : August 25, 2009
Last Update Posted : August 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Anthrax||Drug: Ciprofloxacin and Valortim Drug: Placebo Antibiotic and Valortim Other: Placebo Antibiotic and Placebo Valortim||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||July 2010|
Experimental: Ciprofloxacin and Valortim
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.
Other Name: MDX-1303
Experimental: Placebo Antibiotic and Valortim
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.
Other Name: MDX-1303
Experimental: Placebo Antibiotic and Placebo Valortim
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.
Other Name: Saline
- Determination of changes from baseline for clinical laboratory tests and urinalysis, blood pressure, heart rate, respiratory rate, body temperature, physical examination and ECG [ Time Frame: 134 days ]
- Evaluation of PK parameters for IV administration of ciprofloxacin when dosed concomitantly with Valortim [ Time Frame: 134 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964561
|United States, Kansas|
|Quintiles Phase I Services|
|Overland Park, Kansas, United States, 66211|
|Principal Investigator:||Ralph A. Schutz, M.D.||Quintiles, Inc.|