Healthy VolunteersPhase 1NCT01772836
Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination
A Phase 1 study testing RPX7009, Biapenem and Normal saline in people with Healthy Volunteers and Bacterial Infections, run by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Bacterial Infections
- What is being tested?
- RPX7009, Biapenem and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2013to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.
Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2003 or biapenem) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics and pharmacodynamics of Intravenous Biapenem and RPX7009, administered alone and in combination in healthy adult subjects.
- Conditions
- Healthy Volunteers, Bacterial Infections
- Being tested
- RPX7009, Biapenem, Normal saline
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPX7009Drug
Also called (beta-lactamase inhibitor)
Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
BiapenemDrug
Also called RPX2003
Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
Normal salineDrug
Also called Placebo
Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Single and multiple dose of normal saline Receives: Drug: Normal saline |
| Single dose IV of biapenem or RPX7009 | Experimental | Single dose IV infusion of biapenem or RPX7009 Receives: Drug: RPX7009; Drug: Biapenem |
| Single dose of biapenem or RPX7009 | Experimental | Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment) Receives: Drug: RPX7009; Drug: Biapenem |
| Biapenem and RPX7009 in combination | Experimental | Single dose followed by a multiple dose of biapenem and RPX7009 in combination Receives: Drug: RPX7009; Drug: Biapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety from baseline to 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.
Measured: Day 1 - Day 17
Secondary outcomes (2)
Composite of Pharmacokinetic (PK) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.
Comparison will be performed between the cohorts for the plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Urine PK parameters such as amount excreted and % dose excreted will be calculated from urinary excretion data.
Measured: Day 1 - Day 14
Composite of Pharmacodynamic (PD) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.
Serum for bactericidal titers (SBT) assessments will be collected on Days 1, 4, 7 and 14 (at the end-of-infusion (EOI)), and at 2, 4, and 8 hours after start of infusion.
Measured: Days 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jefferey Loutit, MBChB, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772836
- Sponsor's protocol ID
- Rempex 403
- Status last verified
- Jul 2013
- First submitted
- 16 Jan 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01772836
- Acronym / sponsor ID
- Rempex 403
- Conditions
- Healthy Volunteers, Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.
Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2003 or biapenem) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics and pharmacodynamics of Intravenous Biapenem and RPX7009, administered alone and in combination in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Normal salineSingle and multiple dose of normal saline |
| Single dose IV of biapenem or RPX7009 | Experimental | Drug: RPX7009, Drug: BiapenemSingle dose IV infusion of biapenem or RPX7009 |
| Single dose of biapenem or RPX7009 | Experimental | Drug: RPX7009, Drug: BiapenemSingle IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment) |
| Biapenem and RPX7009 in combination | Experimental | Drug: RPX7009, Drug: BiapenemSingle dose followed by a multiple dose of biapenem and RPX7009 in combination |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPX7009Also: (beta-lactamase inhibitor)Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo) | Drug | Biapenem and RPX7009 in combination, Single dose IV of biapenem or RPX7009, Single dose of biapenem or RPX7009 |
| BiapenemAlso: RPX2003Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo) | Drug | Biapenem and RPX7009 in combination, Single dose IV of biapenem or RPX7009, Single dose of biapenem or RPX7009 |
| Normal salineAlso: PlaceboUp to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo) | Drug | Normal saline |
Primary outcome
Safety from baseline to the end of the study
Time frame: Day 1 - Day 17
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.
2 secondary outcomes
Composite of Pharmacokinetic (PK) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.
Time frame: Day 1 - Day 14
Composite of Pharmacodynamic (PD) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.
Time frame: Days 1-14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jefferey Loutit, MBChB study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPX7009, Biapenem and Normal saline in people with Healthy Volunteers and Bacterial Infections, run by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety from baseline to the end of the study (time frame: Day 1 - Day 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.