Ph1 Study of Valortim and Doxycycline in Humans
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|ClinicalTrials.gov Identifier: NCT00964834|
Recruitment Status : Terminated (Sister trial has SAE investigation underway - sponsor elected to withdraw as study expected to be repeated later)
First Posted : August 25, 2009
Last Update Posted : August 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Anthrax||Drug: Doxycycline and Valortim Drug: Placebo Antibiotic and Valortim Drug: Placebo Antibiotic and Placebo Valortim||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 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) Doxycycline in Healthy Normal Subjects|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Doxycycline and Valortim
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.
Other Name: MDX-1303
Experimental: Placebo Antibiotic and Valortim
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.
Other Name: MDX-1303
Experimental: Placebo Antibiotic and Placebo Valortim
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.
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: 137 days ]
- Evaluation of PK parameters for IV administration of doxycycline when dosed concomitantly with Valortim [ Time Frame: 137 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): NCT00964834
|United States, Kansas|
|Quintiles Phase I Services|
|Overland Park, Kansas, United States, 66211|
|Principal Investigator:||Daivd Mathews, M.D.||Quintiles, Inc.|