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

Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033342
• Other study ID #: MRX4-001
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: September 2017
• Source: MicuRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Safety

Intervention

Drug:
• Oral single doses of MRX-4
Oral single escalating doses of MRX-4
• Oral multiple doses of MRX-4
Multiple ascending doses of MRX-4 given twice daily for 10 days
• 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
• Oral single doses of placebo
Single doses of placebo to match MRX-4
• Oral multiple doses of placebo
Oral placebo given twice daily for 10 days to match the oral MRX-4
• Placebo co-administered with omeprazole
Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MicuRx	Worldwide Clinical Trials

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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