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

MicuRx

Status and phase: Completed; Phase 1

Conditions: Safety

Treatments: Drug: Oral single doses of MRX-4; Drug: MRX-4 co-administered with omeprazole; Drug: Oral multiple doses of placebo; Drug: Oral multiple doses of MRX-4; Drug: Placebo co-administered with omeprazole; Drug: Oral single doses of placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03033342

MRX4-001

Details and patient eligibility

About

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

Enrollment: 122 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 6 patient groups, including a placebo group

Oral single doses of MRX-4

Experimental group

Description:

Single escalating oral doses of MRX-4 from 250 mg to 3000 mg

Treatment:

Drug: Oral single doses of MRX-4

Oral multiple doses of MRX-4

Experimental group

Description:

Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg

Treatment:

Drug: Oral multiple doses of MRX-4

MRX-4 co-administered with omeprazole

Experimental group

Description:

Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.

Treatment:

Drug: MRX-4 co-administered with omeprazole

Oral single doses of placebo

Placebo Comparator group

Description:

Single oral doses of placebo to match MRX-4

Treatment:

Drug: Oral single doses of placebo

Oral multiple doses of placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Oral multiple doses of placebo

Placebo co-administered with omeprazole

Placebo Comparator group

Description:

Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole

Treatment:

Drug: Placebo co-administered with omeprazole