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

NCT03033342 | Completed Phase 1 DMC

• 1 other identifier: MRX4-001
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

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

Conditions

Safety

Keywords

Phase 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions

  Pre-dose through 72 hours post dose

• Safety of MRX-4 co-administered with omeprazole

  Screening through end of study on Day 14

• Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole

  Pre-dose through 72 hours post dose

Study Arms (6)

Oral single doses of MRX-4

EXPERIMENTAL

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

Drug: Oral single doses of MRX-4

Oral multiple doses of MRX-4

EXPERIMENTAL

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

MRX-4 co-administered with omeprazole

EXPERIMENTAL

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

Drug: MRX-4 co-administered with omeprazole

Oral single doses of placebo

PLACEBO COMPARATOR

Single oral doses of placebo to match MRX-4

Drug: Oral single doses of placebo

Oral multiple doses of placebo

PLACEBO COMPARATOR

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

Drug: Oral multiple doses of placebo

Placebo co-administered with omeprazole

PLACEBO COMPARATOR

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

Drug: Placebo co-administered with omeprazole

Interventions

Oral single doses of MRX-4 DRUG

Oral single escalating doses of MRX-4

Oral single doses of MRX-4

Oral multiple doses of MRX-4 DRUG

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

Oral multiple doses of MRX-4

MRX-4 co-administered with omeprazole DRUG

MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7

MRX-4 co-administered with omeprazole

Oral single doses of placebo DRUG

Single doses of placebo to match MRX-4

Oral single doses of placebo

Oral multiple doses of placebo DRUG

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

Oral multiple doses of placebo

Placebo co-administered with omeprazole DRUG

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

Placebo co-administered with omeprazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects

You may not qualify if:

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

Sponsors & Collaborators

• MicuRx: lead
• Worldwide Clinical Trials: collaborator

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 26, 2017
• Study Start: August 2, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 9, 2023

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share