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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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.
Secondary ID [1] 0 0
Rempex 402
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 - 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety from baseline through the end of the study. - 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.
Timepoint [1] 0 0
Study Day 1 to Day 13.
Secondary outcome [1] 0 0
Composite of PK parameters RPX7009 & placebo following single dose administration. - Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Timepoint [1] 0 0
Study Day 1 to Day 12

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
Minimum age
18 Years
Maximum age
55 Years
Gender
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.

- 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).

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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/show/NCT01751269
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
Other publications