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