Clinical trial

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

Name

MRX4-001

Description

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

Trial arms

Trial start

2016-08-02

Estimated PCD

2017-02-01

Trial end

2017-02-01

Status

Completed

Phase

Early phase I

Treatment

Oral single doses of MRX-4

Oral single escalating doses of MRX-4

Arms:

Oral single doses of MRX-4

Oral multiple doses of MRX-4

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

Arms:

Oral multiple doses of MRX-4

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

Arms:

MRX-4 co-administered with omeprazole

Oral single doses of placebo

Single doses of placebo to match MRX-4

Arms:

Oral single doses of placebo

Oral multiple doses of placebo

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

Arms:

Oral multiple doses of placebo

Placebo co-administered with omeprazole

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

Arms:

Placebo co-administered with omeprazole

Size

122

Primary endpoint

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 concentration time data for MRX-4 and its metabolites

Pre-dose through 72 hours post dose

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 122, 'type': 'ACTUAL'}}

Updated at

2023-11-09

1 organization

2 products

1 indication

Product

Indication

Organization

Product