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

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Safety

Intervention / Treatment
-----------------
* Drug: Oral single doses of MRX-4
* Drug: Oral multiple doses of MRX-4
* Drug: MRX-4 co-administered with omeprazole
* Drug: Oral single doses of placebo
* Drug: Oral multiple doses of placebo
* Drug: Placebo co-administered with omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral single doses of MRX-4<br>Single escalating oral doses of MRX-4 from 250 mg to 3000 mg | Drug: Oral single doses of MRX-4<br>* Oral single escalating doses of MRX-4<br>|
| Experimental: Oral multiple doses of MRX-4<br>Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg | Drug: Oral multiple doses of MRX-4<br>* Multiple ascending doses of MRX-4 given twice daily for 10 days<br>|
| Experimental: MRX-4 co-administered with omeprazole<br>Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4. | Drug: MRX-4 co-administered with omeprazole<br>* MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7<br>|
| Placebo Comparator: Oral single doses of placebo<br>Single oral doses of placebo to match MRX-4 | Drug: Oral single doses of placebo<br>* Single doses of placebo to match MRX-4<br>|
| Placebo Comparator: Oral multiple doses of placebo<br>Multiple oral doses of placebo given twice daily for 10 days to match MRX-4 | Drug: Oral multiple doses of placebo<br>* Oral placebo given twice daily for 10 days to match the oral MRX-4<br>|
| Placebo Comparator: Placebo co-administered with omeprazole<br>Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole | Drug: Placebo co-administered with omeprazole<br>* Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of single and multiple ascending doses of MRX-4 | Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events | 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 | Concentration time data for MRX-4 and its metabolites in blood and urine | Pre-dose through 72 hours post dose | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1