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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/NCT01897779




Registration number
NCT01897779
Ethics application status
Date submitted
9/07/2013
Date registered
12/07/2013
Date last updated
29/04/2014

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous RPX2014 and RPX7009 Alone and in Combination in Healthy Adult Subjects
Secondary ID [1] 0 0
Rempex 501
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 - RPX2014
Treatment: Drugs - Placebo
Treatment: Drugs - Combination RPX7009 and RPX2014

Experimental: Single and multiple dose of RPX7009 - Single and multiple dose of RPX7009

Experimental: Single and multiple dose of RPX2014 - Single and multiple dose of RPX2014

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

Experimental: Combination RPX7009 and RPX2014 - Single and Multiple dose of Combination RPX7009 and RPX2014


Treatment: Drugs: RPX7009
Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Treatment: Drugs: RPX2014
Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Treatment: Drugs: Placebo
Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Treatment: Drugs: Combination RPX7009 and RPX2014
Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
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
Timepoint [1] 0 0
Study Day 1 to Day 14
Secondary outcome [1] 0 0
Composite of PK parameters RPX7009, RPX2014, combination of RPX7009 and RPX2014 & placebo following single and multiple dose administration.
Timepoint [1] 0 0
Study Day1 to Day 14

Eligibility
Key inclusion criteria
1. Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of
screening.

2. Body mass index (BMI) = 18.5 and = 29.9 (kg/m2) and weight between 55.0 and 100.0 kg
(inclusive).

3. Medically healthy with clinically insignificant screening results (e.g., laboratory
profiles, medical histories, ECGs, physical examination) as deemed by the PI.

4. Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months
prior to Day 1.

5. Voluntarily consent to participate in the study.

6. Sexually abstinent or agree to use two approved methods of contraception.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological,
or psychiatric disease.

2. Positive urine drug/alcohol testing at screening or check-in (Day -1).

3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C antibodies (HCV).

4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.

5. 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.

6. Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day
1.

7. Plasma donation within 7 days prior to Day 1.

8. Participation in another investigational clinical trial within 30 days prior to Day 1.

9. 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
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
94
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 studied in combination with a carbapenem
(RPX2014) to treat bacterial infections, including those due to multi-drug resistant
bacteria.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01897779
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffery Loutit
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/NCT01897779