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

Randomized, Double-Blind, Placebo-Controlled Three-Part Phase 1 Study of Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX-4 Administered Orally to Healthy Volunteers in Single and Multiple Ascending Dose Cohorts to Evaluate Drug Interactions With Omeprazole

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03033342

Enrollment

122

Registered

2017-01-26

Start date

2016-08-02

Completion date

2017-02-01

Last updated

2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety

Keywords

Phase 1

Brief 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

Interventions

DRUGOral single doses of MRX-4

Oral single escalating doses of MRX-4

DRUGOral multiple doses of MRX-4

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

DRUGMRX-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

DRUGOral single doses of placebo

Single doses of placebo to match MRX-4

DRUGOral multiple doses of placebo

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

DRUGPlacebo co-administered with omeprazole

Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of single and multiple ascending doses of MRX-4	Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 14 (Part III)	Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events
Summary of concentration time data for MRX-4 and its metabolites	Pre-dose through 72 hours post dose	Concentration time data for MRX-4 and its metabolites in blood and urine

Secondary

Measure	Time frame	Description
Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions	Pre-dose through 72 hours post dose	Concentration time data for MRX-4 and its metabolites in blood and urine under fed and fasted conditions
Safety of MRX-4 co-administered with omeprazole	Screening through end of study on Day 14	Summary of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters and adverse events
Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole	Pre-dose through 72 hours post dose	Concentation time data for MRX-4 and its metabolites in blood and urine with and without omeprazole

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026