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

Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033329
• Other study ID #: MRX4-002
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2017
• Last updated: March 20, 2018
• Start date: October 2016
• Est. completion date: March 2018

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• 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:
• Single intravenous doses of MRX-4
Intravenous single escalating doses of MRX-4
• Single intravenous doses of placebo
Intravenous single doses of placebo to match MRX-4
• Multiple intravenous doses of MRX-4
Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days
• Multiple intravenous doses of placebo
Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days
• Single dose of intravenous and oral MRX-4
Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4

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 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	Plasma concentration time data for MRX-4 and its metabolites	Individual and mean plasma concentration time data for MRX-4 and its metabolites	Pre-dose through 72 hours post dose
Secondary	Bioavailability of MRX-I and other MRX-4 metabolites	Levels of MRX-4 and its metabolites in blood	Pre-dose through 72 hours post dose
Secondary	Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites	Levels of MRX-4 and its metabolites in blood	Pre-dose through 72 hours post dose
Secondary	Elimination of MRX-4 and its metabolites in the urine following single dose adminstration	Levels of MRX-4 and its metabolites in urine	Pre-dose through 72 hours post dose