Phase I Trial to Determine the Safety and Pharmacokinetics of CRS3123.

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Clostridium Difficile Infection
Interventions
OTHER

Placebo

Placebo capsules have the same inert components as CRS3123; 2 subjects randomized in each cohorts recieve 200mg, 400mg; and 600mg, or 100mg are planned respectively given orally every 12 hours for 10 days

DRUG

CRS3123

CRS3123, a methionyl-tRNA synthetase inhibitor, formulated in 100 and 200 mg capsules; 8 subjects randomized in Cohorts A through C receive doses of 200 mg, 400 mg; and 600 mg or 100mg are planned respectively given orally every 12 hours for 10 days.

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

NCT02106338 - Phase I Trial to Determine the Safety and Pharmacokinetics of CRS3123. | Biotech Hunter | Biotech Hunter