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

A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration

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.

Study Overview

• Status: Completed
• Conditions: Safety
• Intervention / Treatment: Drug: Single intravenous doses of MRX-4; Drug: Single intravenous doses of placebo; Drug: Multiple intravenous doses of MRX-4; Drug: Multiple intravenous doses of placebo; Drug: Single dose of intravenous and oral MRX-4

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

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

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: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single intravenous doses of MRX-4; Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg	Drug: Single intravenous doses of MRX-4; Intravenous single escalating doses of MRX-4
PLACEBO_COMPARATOR: Single intravenous doses of placebo; Single intravenous doses of placebo to match MRX-4	Drug: Single intravenous doses of placebo; Intravenous single doses of placebo to match MRX-4
ACTIVE_COMPARATOR: 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	Drug: Multiple intravenous doses of MRX-4; Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days
PLACEBO_COMPARATOR: Multiple intravenous doses of placebo; Twice daily intravenous doses of placebo to match MRX-4 for 10 days	Drug: Multiple intravenous doses of placebo; Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days
ACTIVE_COMPARATOR: Single dose of intravenous and oral MRX-4; Crossover of single dose of intravenous and oral MRX-4	Drug: Single dose of intravenous and oral MRX-4; Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4

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 statistics 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 visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration time data for MRX-4 and its metabolites	Individual and mean plasma concentration time data for MRX-4 and its metabolites	Pre-dose through 72 hours post dose
Bioavailability of MRX-I and other MRX-4 metabolites	Levels of MRX-4 and its metabolites in blood	Pre-dose through 72 hours post dose
Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites	Levels of MRX-4 and its metabolites in blood	Pre-dose through 72 hours post dose
Elimination of MRX-4 and its metabolites in the urine following single dose adminstration	Levels of MRX-4 and its metabolites in urine	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): October 1, 2016
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (ESTIMATE): January 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MRX4-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO