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

NCT ID: NCT03033329

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single intravenous doses of MRX-4

Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg

Group Type EXPERIMENTAL

Single intravenous doses of MRX-4

Intervention Type DRUG

Intravenous single escalating doses of MRX-4

Single intravenous doses of placebo

Single intravenous doses of placebo to match MRX-4

Group Type PLACEBO_COMPARATOR

Single intravenous doses of placebo

Intervention Type DRUG

Intravenous single doses of placebo to match 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

Group Type ACTIVE_COMPARATOR

Multiple intravenous doses of MRX-4

Intervention Type DRUG

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

Multiple intravenous doses of placebo

Twice daily intravenous doses of placebo to match MRX-4 for 10 days

Group Type PLACEBO_COMPARATOR

Multiple intravenous doses of placebo

Intervention Type DRUG

Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days

Single dose of intravenous and oral MRX-4

Crossover of single dose of intravenous and oral MRX-4

Group Type ACTIVE_COMPARATOR

Single dose of intravenous and oral MRX-4

Intervention Type DRUG

Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4

Interventions

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Single intravenous doses of MRX-4

Intravenous single escalating doses of MRX-4

Intervention Type DRUG

Single intravenous doses of placebo

Intravenous single doses of placebo to match MRX-4

Intervention Type DRUG

Multiple intravenous doses of MRX-4

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

Intervention Type DRUG

Multiple intravenous doses of placebo

Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects

Exclusion Criteria

* Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Worldwide Clinical Trials

OTHER

Sponsor Role collaborator

MicuRx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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MRX4-002

Identifier Type: -

Identifier Source: org_study_id

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