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

Phase 1

Completed

• Conditions: Safety
• Interventions: Drug: Multiple intravenous doses of MRX-4; Drug: Multiple intravenous doses of placebo; Drug: Single dose of intravenous and oral MRX-4; Drug: Single intravenous doses of MRX-4; Drug: Single intravenous doses of placebo

• Registration Number: NCT03033329
• Lead Sponsor: MicuRx

Brief Summary

A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-01
• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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
Multiple intravenous doses of MRX-4	Multiple intravenous doses of MRX-4	Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg
Multiple intravenous doses of placebo	Multiple intravenous doses of placebo	Twice daily intravenous doses of placebo to match MRX-4 for 10 days
Single dose of intravenous and oral MRX-4	Single dose of intravenous and oral MRX-4	Crossover of single dose of intravenous and oral MRX-4
Single intravenous doses of MRX-4	Single intravenous doses of MRX-4	Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg
Single intravenous doses of placebo	Single intravenous doses of placebo	Single intravenous doses of placebo to match 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 15 (Part III)	Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events

Secondary Outcome Measures

Name	Time	Method
Plasma concentration time data for MRX-4 and its metabolites	Pre-dose through 72 hours post dose	Individual and mean plasma concentration time data for MRX-4 and its metabolites
Bioavailability of MRX-I and other MRX-4 metabolites	Pre-dose through 72 hours post dose	Levels of MRX-4 and its metabolites in blood
Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites	Pre-dose through 72 hours post dose	Levels of MRX-4 and its metabolites in blood
Elimination of MRX-4 and its metabolites in the urine following single dose adminstration	Pre-dose through 72 hours post dose	Levels of MRX-4 and its metabolites in urine