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

NCT03033342 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-11-09

No results posted yet for this study

Summary

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

Conditions

  • Safety

Interventions

DRUG

Oral single doses of MRX-4

Oral single escalating doses of MRX-4

DRUG

Oral multiple doses of MRX-4

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

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

DRUG

Oral single doses of placebo

Single doses of placebo to match MRX-4

DRUG

Oral multiple doses of placebo

Oral placebo given twice daily for 10 days to match the oral MRX-4

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

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • MicuRx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-02
Primary Completion
2017-02-01
Completion
2017-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033342 on ClinicalTrials.gov