NCT03033329

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 22, 2018

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

January 16, 2017

Last Update Submit

March 20, 2018

Conditions

Safety

Outcome Measures

Primary Outcomes (1)

  • Safety of single and multiple ascending doses of MRX-4

    Summary statistics 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 visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)

Secondary Outcomes (4)

  • Plasma concentration time data for MRX-4 and its metabolites

    Pre-dose through 72 hours post dose

  • Bioavailability of MRX-I and other MRX-4 metabolites

    Pre-dose through 72 hours post dose

  • Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites

    Pre-dose through 72 hours post dose

  • Elimination of MRX-4 and its metabolites in the urine following single dose adminstration

    Pre-dose through 72 hours post dose

Study Arms (5)

Single intravenous doses of MRX-4

EXPERIMENTAL

Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg

Drug: Single intravenous doses of MRX-4

Single intravenous doses of placebo

PLACEBO COMPARATOR

Single intravenous doses of placebo to match MRX-4

Drug: Single intravenous doses of placebo

Multiple intravenous doses of MRX-4

ACTIVE COMPARATOR

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 intravenous doses of placebo

PLACEBO COMPARATOR

Twice daily intravenous doses of placebo to match MRX-4 for 10 days

Drug: Multiple intravenous doses of placebo

Single dose of intravenous and oral MRX-4

ACTIVE COMPARATOR

Crossover of single dose of intravenous and oral MRX-4

Drug: Single dose of intravenous and oral MRX-4

Interventions

Single intravenous doses of MRX-4DRUG

Intravenous single escalating doses of MRX-4

Single intravenous doses of MRX-4
Single intravenous doses of placeboDRUG

Intravenous single doses of placebo to match MRX-4

Single intravenous doses of placebo
Multiple intravenous doses of MRX-4DRUG

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

Multiple intravenous doses of MRX-4
Multiple intravenous doses of placeboDRUG

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

Multiple intravenous doses of placebo
Single dose of intravenous and oral MRX-4DRUG

Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4

Single dose of intravenous and oral MRX-4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 26, 2017

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 22, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share