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

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ClinicalTrials.gov Identifier: NCT03033329
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
MicuRx

Brief Summary:
A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.

Condition or disease Intervention/treatment Phase
Safety Drug: Single intravenous doses of MRX-4 Drug: Single intravenous doses of placebo Drug: Multiple intravenous doses of MRX-4 Drug: Multiple intravenous doses of placebo Drug: Single dose of intravenous and oral MRX-4 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: Single intravenous doses of MRX-4
Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg
Drug: Single intravenous doses of MRX-4
Intravenous single escalating doses of MRX-4

Placebo Comparator: Single intravenous doses of placebo
Single intravenous doses of placebo to match MRX-4
Drug: Single intravenous doses of placebo
Intravenous single doses of placebo to match MRX-4

Active Comparator: Multiple intravenous doses of MRX-4
Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg
Drug: Multiple intravenous doses of MRX-4
Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days

Placebo Comparator: Multiple intravenous doses of placebo
Twice daily intravenous doses of placebo to match MRX-4 for 10 days
Drug: Multiple intravenous doses of placebo
Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days

Active Comparator: Single dose of intravenous and oral MRX-4
Crossover of single dose of intravenous and oral MRX-4
Drug: Single dose of intravenous and oral MRX-4
Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4




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 15 (Part III) ]
    Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events


Secondary Outcome Measures :
  1. Plasma concentration time data for MRX-4 and its metabolites [ Time Frame: Pre-dose through 72 hours post dose ]
    Individual and mean plasma concentration time data for MRX-4 and its metabolites

  2. Bioavailability of MRX-I and other MRX-4 metabolites [ Time Frame: Pre-dose through 72 hours post dose ]
    Levels of MRX-4 and its metabolites in blood

  3. Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites [ Time Frame: Pre-dose through 72 hours post dose ]
    Levels of MRX-4 and its metabolites in blood

  4. Elimination of MRX-4 and its metabolites in the urine following single dose adminstration [ Time Frame: Pre-dose through 72 hours post dose ]
    Levels of MRX-4 and its metabolites in urine



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: NCT03033329    
Other Study ID Numbers: MRX4-002
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No