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

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ClinicalTrials.gov Identifier: NCT03033342
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
MicuRx

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


Condition or disease Intervention/treatment Phase
Safety 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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Placebo Controlled Three-Part Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX 4 Administered Orally to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and to Evaluate Drug Interactions With Omeprazole
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole

Arm Intervention/treatment
Experimental: Oral single doses of MRX-4
Single escalating oral doses of MRX-4 from 250 mg to 3000 mg
Drug: Oral single doses of MRX-4
Oral single escalating doses of MRX-4

Experimental: Oral multiple doses of MRX-4
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
Multiple ascending doses of MRX-4 given twice daily for 10 days

Experimental: MRX-4 co-administered with omeprazole
Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.
Drug: 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

Placebo Comparator: Oral single doses of placebo
Single oral doses of placebo to match MRX-4
Drug: Oral single doses of placebo
Single doses of placebo to match MRX-4

Placebo Comparator: Oral multiple doses of placebo
Multiple oral doses of placebo given twice daily for 10 days to match MRX-4
Drug: Oral multiple doses of placebo
Oral placebo given twice daily for 10 days to match the oral MRX-4

Placebo Comparator: Placebo co-administered with omeprazole
Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole
Drug: Placebo co-administered with omeprazole
Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7




Primary Outcome Measures :
  1. Safety of single and multiple ascending doses of MRX-4 [ Time Frame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 14 (Part III) ]
    Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events

  2. Summary of concentration time data for MRX-4 and its metabolites [ Time Frame: Pre-dose through 72 hours post dose ]
    Concentration time data for MRX-4 and its metabolites in blood and urine


Secondary Outcome Measures :
  1. Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions [ Time Frame: Pre-dose through 72 hours post dose ]
    Concentration time data for MRX-4 and its metabolites in blood and urine under fed and fasted conditions

  2. Safety of MRX-4 co-administered with omeprazole [ Time Frame: Screening through end of study on Day 14 ]
    Summary of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters and adverse events

  3. Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole [ Time Frame: Pre-dose through 72 hours post dose ]
    Concentation time data for MRX-4 and its metabolites in blood and urine with and without omeprazole



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder
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Responsible Party: MicuRx
ClinicalTrials.gov Identifier: NCT03033342    
Other Study ID Numbers: MRX4-001
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study results will be published in the future
Keywords provided by MicuRx:
Phase 1
Additional relevant MeSH terms:
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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action