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

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

Study Overview

• Status: Completed
• Conditions: Safety
• Intervention / Treatment: Drug: Oral single doses of MRX-4; Drug: Oral multiple doses of MRX-4; Drug: MRX-4 co-administered with omeprazole; Drug: Oral single doses of placebo; Drug: Oral multiple doses of placebo; Drug: Placebo co-administered with omeprazole

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral single doses of MRX-4; Single escalating oral doses of MRX-4 from 250 mg to 3000 mg	Drug: Oral single doses of MRX-4; Oral single escalating doses of MRX-4
Experimental: 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	Drug: Oral multiple doses of MRX-4; Multiple ascending doses of MRX-4 given twice daily for 10 days
Experimental: MRX-4 co-administered with omeprazole; Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.	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
Placebo Comparator: Oral single doses of placebo; Single oral doses of placebo to match MRX-4	Drug: Oral single doses of placebo; Single doses of placebo to match MRX-4
Placebo Comparator: Oral multiple doses of placebo; Multiple oral doses of placebo given twice daily for 10 days to match MRX-4	Drug: Oral multiple doses of placebo; Oral placebo given twice daily for 10 days to match the oral MRX-4
Placebo Comparator: Placebo co-administered with omeprazole; Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MicuRx
• Collaborators: Worldwide Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimated): January 26, 2017

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Phase 1
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: MRX4-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study results will be published in the future