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Trial registered on ANZCTR


Registration number
ACTRN12613001212741
Ethics application status
Not yet submitted
Date submitted
2/11/2013
Date registered
5/11/2013
Date last updated
5/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MRX-I Tablets in Healthy Adult Subjects (Part 3)
Scientific title
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MRX-I Tablets in Healthy Adult Subjects (Part 3)
Secondary ID [1] 283502 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study is for healthy volunteers. The intended use of the investigational product is the treatment of serious gram-positive bacterial infections 290421 0
Condition category
Condition code
Infection 290811 290811 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 3 has a double-blind, comparative, double-dummy, two cohort design. This part of the study will enroll 12 subjects in each of two cohorts (total of 24 subjects). Subjects will be screened and then randomized in parallel to receive either oral MRX-I (800mg) or oral linezolid (600mg). Both will be administered once every 12 hours for 28 days. Subjects will be confined in a Clinical Research Unit during the dosing periods and will be monitored to ensure compliance with dosing.
Intervention code [1] 288208 0
Treatment: Drugs
Comparator / control treatment
active control: linezolid
placebo for linezolid and MRX-I
Control group
Active

Outcomes
Primary outcome [1] 290807 0
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.
Timepoint [1] 290807 0
From the time of signed consent through the end of study date which occurs on Day 35
Secondary outcome [1] 305338 0
To determine the pharmacokinetics of MRX-I as assessed through blood and urine collection during the study
Timepoint [1] 305338 0
Part 3: On Day 1, obtain blood for PK analyses immediately prior to the first administration of MRX-I Tablets (active, dummy, or placebo), and at 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, and 24 hours after the first administration of MRX-I Tablets (active, dummy, or placebo); obtain the 24-hour sample prior to the morning administration of study drug on Day 2. On Day 20 and Day 21, obtain blood for PK analyses immediately prior to the first administration of MRX-I Tablets (active, dummy, or placebo) for that day. On Day 28, obtain blood for PK analyses immediately prior to the final administration of MRX-I Tablets (active, dummy, or placebo), and at 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, and 48 hours after the final administration of MRX-I Tablets (active, dummy, or placebo). Urine PK samples will be timed from administration of MRX-I Tablets (active, dummy, or placebo), rather than from administration of oral linezolid. On Day 1, obtain urine for PK analysis immediately prior to the first administration of MRX-I Tablets (active, dummy, or placebo) and at 0-2, 2-4, 4-8, 8-12, and 12-24 hours after the first administration of MRX-I Tablets (active, dummy, or placebo); obtain the 12-24 hour sample prior to the morning administration of MRX-I Tablets (active, dummy, or placebo) on Day 2. On Day 28, obtain urine for PK analysis immediately prior to the final administration of MRX-I Tablets (active, dummy, or placebo) and at 0-2, 2-4, 4-8, 8-12, 12-24, and 24-36 hours after the final administration of MRX-I Tablets (active, dummy, or placebo).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288203 0
Commercial sector/Industry
Name [1] 288203 0
MicuRx Pharmaceuticals
Country [1] 288203 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CPR Pharma Services
Address
Suite C, 32 West Thebarton Road
Thebarton SA 5031
Country
Australia
Secondary sponsor category [1] 286929 0
None
Name [1] 286929 0
Address [1] 286929 0
Country [1] 286929 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290115 0
BellBerry HREC
Ethics committee address [1] 290115 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 290115 0
Australia
Date submitted for ethics approval [1] 290115 0
31/10/2013
Approval date [1] 290115 0
Ethics approval number [1] 290115 0

Summary
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 reference ACTRN12613001206718)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44038 0
Dr Jason Lickliter, MBBS PhD FRACP
Address 44038 0
Nucleus Network Limited Level
5 Burnet Institute AMREP Precinct
89 Commercial Road
Melbourne Victoria 3004
Country 44038 0
Australia
Phone 44038 0
+61 3 9076 8960
Fax 44038 0
Email 44038 0
[email protected]
Contact person for public queries
Name 44039 0
Jason Lickliter, MBBS PhD FRACP
Address 44039 0
Nucleus Network Limited Level
5 Burnet Institute AMREP Precinct
89 Commercial Road
Melbourne Victoria 3004
Country 44039 0
Australia
Phone 44039 0
+61 3 9076 8960
Fax 44039 0
Email 44039 0
[email protected]
Contact person for scientific queries
Name 44040 0
Paul Eckburg
Address 44040 0
MicuRx Pharmaceuticals, Inc.
3916 Trust Way Hayward, CA 94545
Country 44040 0
United States of America
Phone 44040 0
+1-650-888-3475
Fax 44040 0
Email 44040 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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