Ph1 Study of Valortim and Ciprofloxacin in Humans
|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 ]
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.|