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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/NCT01772836




Registration number
NCT01772836
Ethics application status
Date submitted
16/01/2013
Date registered
21/01/2013
Date last updated
11/07/2013

Titles & IDs
Public title
Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination in Healthy Adult Subjects.
Secondary ID [1] 0 0
Rempex 403
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Bacterial Infections 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RPX7009
Treatment: Drugs - Biapenem
Treatment: Drugs - Normal saline

Placebo Comparator: Normal saline - Single and multiple dose of normal saline

Experimental: Single dose IV of biapenem or RPX7009 - Single dose IV infusion of biapenem or RPX7009

Experimental: Single dose of biapenem or RPX7009 - Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment)

Experimental: Biapenem and RPX7009 in combination - Single dose followed by a multiple dose of biapenem and RPX7009 in combination


Treatment: Drugs: RPX7009
Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Treatment: Drugs: Biapenem
Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Treatment: Drugs: Normal saline
Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety from baseline to the end of the study
Timepoint [1] 0 0
Day 1 - Day 17
Secondary outcome [1] 0 0
Composite of Pharmacokinetic (PK) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.
Timepoint [1] 0 0
Day 1 - Day 14
Secondary outcome [2] 0 0
Composite of Pharmacodynamic (PD) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.
Timepoint [2] 0 0
Days 1-14

Eligibility
Key inclusion criteria
- Healthy adult males and/or females, 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

- Hypersensitivity or idiosyncratic reaction to beta-lactam antibiotics (e.g.
penicillins, cephalosporins, carbapenems, etc.).

- 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).

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01772836
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jefferey Loutit, MBChB
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01772836