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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01751269
Registration number
NCT01751269
Ethics application status
Date submitted
13/12/2012
Date registered
17/12/2012
Date last updated
24/07/2013
Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects
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Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.
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Secondary ID [1]
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Rempex 402
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Bacterial Infections
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RPX7009
Treatment: Drugs - Placebo
Experimental: Ascending Single and Multiple dose of RPX7009 - Ascending Single and Multiple dose of RPX7009
Placebo Comparator: Normal Saline - Ascending Single and multiple dose of normal saline.
Treatment: Drugs: RPX7009
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
Treatment: Drugs: Placebo
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety from baseline through the end of the study.
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Assessment method [1]
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Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
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Timepoint [1]
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Study Day 1 to Day 13.
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Secondary outcome [1]
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Composite of PK parameters RPX7009 & placebo following single dose administration.
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Assessment method [1]
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Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
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Timepoint [1]
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Study Day 1 to Day 12
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Eligibility
Key inclusion criteria
- Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of
age
- Body mass index (BMI) = 18.5 and = 29.9 (kg/m2) and weight between 55.0 and 100.0 kg
(inclusive).
- Medically healthy with clinically insignificant screening results
- Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day
1.
- Sexually abstinent or use acceptable methods of birth control
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological,
or psychiatric disease.
- History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
- Documented hypersensitivity reaction or anaphylaxis to any medication.
- Use of any over-the-counter (OTC) medication, including herbal products and vitamins,
within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed
for acute events at the discretion of the PI.
- Plasma donation within 7 days prior to Day 1.
- Subjects who have any abnormalities on laboratory values at screening or check-in (Day
-1).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2013
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem
to treat bacterial infections, including those due to multi-drug resistant bacteria.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01751269
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jefferey Loutit, MBChB
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Address
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Sponsor GmbH
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01751269
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