None listed
Conditions
Brief summary
The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of MRX-I, an orally administered antibiotic. There will be three Parts to the study. Part 1 will assess the safety, tolerability and pharmacokinetics of single dose administrations of MRX-I compared with placebo. Part 2 will assess the safety, tolerability and pharmacokinetics of a 14 day administration of MRX-I compared with placebo. Part 3 will compare the safety and tolerability of a 28 day administration of MRX-I with linezolid an active comparator. (please refer to ACTRN12613001206718)
Interventions
Part 2 has a double-blind, placebo-controlled, single cohort design. This part of the study will enroll 12 subjects in a single Dose Cohort (MRX-I Tablets 800 mg given once every 12 hours or placebo). Subjects will be screened and then randomized to study drug (active MRX-I or placebo) within this single Dose Cohort. Equal numbers of males and females will be randomized to either active or placebo study drug: 10 active MRX-I (5 M:5 F) and 2 placebo (1 M:1 F). Subjects will be treated for 14 day
Part 2 has a double-blind, placebo-controlled, single cohort design. This part of the study will enroll 12 subjects in a single Dose Cohort (MRX-I Tablets 800 mg given once every 12 hours or placebo). Subjects will be screened and then randomized to study drug (active MRX-I or placebo) within this single Dose Cohort. Equal numbers of males and females will be randomized to either active or placebo study drug: 10 active MRX-I (5 M:5 F) and 2 placebo (1 M:1 F). Subjects will be treated for 14 days. Subjects will be confined in a Clinical Research Unit during the dosing periods and will be monitored to ensure compliance with dosing.
Sponsors
CPR Pharma Services
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Outcome results
None listed