A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MRX-I Tablets in Healthy Adult Subjects (Part 2)

Phase 1

• Conditions: This study is for healthy volunteers. The intended use of the investigational product is the treatment of serious gram-positive bacterial infections; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12613001211752
• Lead Sponsor: CPR Pharma Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

This study will be conducted in normal, healthy, adult, male or female non-Chinese subjects aged between 18-50 years and with a BMI greater than or equal to 18 and less than or equal to 32. Eligible subjects will be in good health without signs or symptoms of current illness and with predose clinical and laboratory examinations without clinically significant findings.

Exclusion Criteria

- History of any intolerance, hypersensitivity or allergic reaction to any oxazolidinone antibiotic
- History of bone marrow suppression or any type of anemia, leukopenia, thrombocytopenia, or pancytopenia
- History of peripheral or optic neuropathy
- History of hypoglycemia; low fasting glucose at screening (blood glucose level less than 50 mg/dL), even if normal upon repeat testing
- History of known or suspected serotonin syndrome, neuroleptic malignant syndrome, or carcinoid syndrome
- History of known or suspected lactic acidosis, unexplained acidosis, recurrent nausea and vomiting, or low bicarbonate levels associated with medication
- History of known or suspected Clostridium difficile-associated diarrhea
- Surgery or any acute illness within the past three months determined by the PI to be clinically relevant
- Females who are pregnant or nursing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as assessed through the determination and recording of the occurrence of AEs as well as by adverse changes in vital signs, ECG (e.g. QTc interval) parameters, and laboratory data. [From the time of signed consent through the end of study date which occurs on Day 23]