NCT02178254View on ClinicalTrials.gov

Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Pseudomonas Infection
Interventions
DRUG

Fosfomycin tromethamine

A phosphonic acid derivative is the mono-acid salt of Fosfomycin with Tromethamine. Sequence 1-3 receive 3 grams oral sachet

DRUG

Fosfomycin disodium

ZTI-01 is a phosphonic acid derivative formulated as a disodium salt intravenous formulation. ZTI-01 acts by inhibiting peptidoglycan assembly, thereby disrupting cell wall synthesis. Sequence 1-3 receive 1 gram and 8 grams of Intravenous ZTI-01 for 1-hour infusion

Trial Locations (1)

66211-1553

Quintiles Phase I Services - Overland Park, Overland Park

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02178254 - Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects | Biotech Hunter | Biotech Hunter