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

MicuRx90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Safety

Interventions

Single intravenous doses of MRX-4DRUG

Intravenous single escalating doses of MRX-4

Single intravenous doses of placeboDRUG

Intravenous single doses of placebo to match MRX-4

Multiple intravenous doses of MRX-4DRUG

Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects Exclusion Criteria: * Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder

Outcomes

Primary Outcomes

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

Time frame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)

Secondary Outcomes

Plasma concentration time data for MRX-4 and its metabolites

Individual and mean plasma concentration time data for MRX-4 and its metabolites

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Pre-dose through 72 hours post dose

Data from ClinicalTrials.gov

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