NCT03033342

Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4

Randomized, Double-Blind, Placebo-Controlled Three-Part Phase 1 Study of Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX-4 Administered Orally to Healthy Volunteers in Single and Multiple Ascending Dose Cohorts to Evaluate Drug Interactions With Omeprazole

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: MicuRx · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in: single dose escalation study of increasing doses of MRX-4 given by mouth others will participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth. other cohorts of subjects will participate in the study to evaluate the impact of concomitant food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	Oral single doses of MRX-4	Oral single escalating doses of MRX-4
DRUG	Oral multiple doses of MRX-4	Multiple ascending doses of MRX-4 given twice daily for 10 days
DRUG	MRX-4 co-administered with omeprazole	MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
DRUG	Oral single doses of placebo	Single doses of placebo to match MRX-4
DRUG	Oral multiple doses of placebo	Oral placebo given twice daily for 10 days to match the oral MRX-4
DRUG	Placebo co-administered with omeprazole	Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7

Timeline

• Start date: 2016-08-02
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2017-01-26
• Last updated: 2023-11-09