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Completed

NCT Number: NCT03033329

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

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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Key information

Conditions

Safety

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects

Exclusion criteria

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

Treatment and study plan

Single intravenous doses of MRX-4

Drug

Intravenous single escalating doses of MRX-4

Single intravenous doses of placebo

Drug

Intravenous single doses of placebo to match MRX-4

Multiple intravenous doses of MRX-4

Drug

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

Multiple intravenous doses of placebo

Drug

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

Single dose of intravenous and oral MRX-4

Drug

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

Primary outcomes

  1. Safety of single and multiple ascending doses of MRX-4

    Time frame: 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 outcomes

  1. Plasma concentration time data for MRX-4 and its metabolites

    Time frame: Pre-dose through 72 hours post dose

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

  2. Bioavailability of MRX-I and other MRX-4 metabolites

    Time frame: Pre-dose through 72 hours post dose

    Levels of MRX-4 and its metabolites in blood

  3. Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites

    Time frame: Pre-dose through 72 hours post dose

    Levels of MRX-4 and its metabolites in blood

  4. Elimination of MRX-4 and its metabolites in the urine following single dose adminstration

    Time frame: Pre-dose through 72 hours post dose

    Levels of MRX-4 and its metabolites in urine

Sponsors and collaborators

Lead sponsor

MicuRx

Industry

Collaborators

  • Worldwide Clinical Trials

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2017
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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