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

Phase 1

Completed

• Conditions: Safety
• Interventions: Drug: Oral single doses of MRX-4; Drug: Oral multiple doses of MRX-4; Drug: Placebo co-administered with omeprazole; Drug: Oral single doses of placebo; Drug: Oral multiple doses of placebo; Drug: MRX-4 co-administered with omeprazole

• Registration Number: NCT03033342
• Lead Sponsor: MicuRx

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-02
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2017-09
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Healthy subjects

Exclusion Criteria

• Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral single doses of MRX-4	Oral single doses of MRX-4	Single escalating oral doses of MRX-4 from 250 mg to 3000 mg
Oral multiple doses of MRX-4	Oral multiple doses of MRX-4	Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg
Placebo co-administered with omeprazole	Placebo co-administered with omeprazole	Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole
Oral single doses of placebo	Oral single doses of placebo	Single oral doses of placebo to match MRX-4
Oral multiple doses of placebo	Oral multiple doses of placebo	Multiple oral doses of placebo given twice daily for 10 days to match MRX-4
MRX-4 co-administered with omeprazole	MRX-4 co-administered with omeprazole	Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.

Primary Outcome Measures

Name	Time	Method
Safety of single and multiple ascending doses of MRX-4	Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 14 (Part III)	Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events
Summary of concentration time data for MRX-4 and its metabolites	Pre-dose through 72 hours post dose	Concentration time data for MRX-4 and its metabolites in blood and urine

Secondary Outcome Measures

Name	Time	Method
Safety of MRX-4 co-administered with omeprazole	Screening through end of study on Day 14	Summary of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters and adverse events
Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole	Pre-dose through 72 hours post dose	Concentation time data for MRX-4 and its metabolites in blood and urine with and without omeprazole
Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions	Pre-dose through 72 hours post dose	Concentration time data for MRX-4 and its metabolites in blood and urine under fed and fasted conditions