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

Clostridium Difficile Infection Clinical Trial

Official title: Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Phase I Trial to Determine the Safety and Pharmacokinetics of CRS3123 Administered Orally to Healthy Adults

Status Completed

Clinical Trial Summary

This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple ascending dose study to evaluate the safety and tolerability of CRS3123, a methionyl-tRNA synthetase inhibitor. In this study, doses of 200, 400, and 600 mg, or 100mg are planned and will be given orally every 12 hours for 10 days. Up to 30 healthy male and female subjects 18 to 45 years, inclusive. The primary objective: of the study is to determine the safety and tolerability of escalating doses of CRS3123 following oral administration of multiple doses to healthy adults. The study duration is 46 weeks.

Clinical Trial Description

This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple ascending dose study to evaluate the safety and tolerability of CRS3123,a fully synthetic, oral, antimicrobial that targets methionyl-tRNA synthetase of gram-positive bacteria, including Clostridium difficile. This protocol will study oral doses of 200, 400, and 600 mg, or 100mg given orally every 12 hours for 10 days. Subjects will be divided into 3 cohorts, A, B, and C. Cohorts A and C will be given 200mg and 600mg of CRS3123 or placebo.The dose for cohort B and study progression and dose escalation to Cohorts B and C will require a full (planned) SMC review of all safety data obtained through Day 18. Should safety data review of the 200 mg dose result in an unfavorable safety profile, the study design allows for reduction in dose to 100 mg to be given in Cohort B. If this is the case, there will be no Cohort C. Up to 30 healthy male and female subjects 18 to 45 years, inclusive. The primary objective: of the study is to determine the safety and tolerability of escalating doses of CRS3123 following oral administration of multiple doses to healthy adults. The secondary objective will be to determine the plasma, urine and fecal concentrations and systemic exposure of CRS3123 after multiple oral doses.The study duration is 46 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Infection

• NCT number: NCT02106338
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: June 2014
• Completion date: December 2014