Healthy VolunteersPhase 1NCT01751269
Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects
A Phase 1 study testing RPX7009 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2012to Jul 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 (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
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.
- 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).
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 of Intravenous RPX7009 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 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 of RPX7009, administered alone, in healthy adult subjects.
- Conditions
- Healthy Volunteers, Bacterial Infections
- Being tested
- RPX7009, Placebo
- 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)
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
PlaceboDrug
Also called Normal saline
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Ascending Single and Multiple dose of RPX7009 | Experimental | Ascending Single and Multiple dose of RPX7009 Receives: Drug: RPX7009 |
| Normal Saline | Placebo comparator | Ascending Single and multiple dose of normal saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study Day 1 to Day 13.
Secondary outcomes (1)
Composite of PK parameters RPX7009 & placebo following single dose administration.
Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Measured: Study Day 1 to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 80 participants (actual)
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
- NCT01751269
- Sponsor's protocol ID
- Rempex 402
- Status last verified
- Jul 2013
- First submitted
- 13 Dec 2012
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Griffith DC, Loutit JS, Morgan EE, Durso S, Dudley MN. Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the beta-Lactamase Inhibitor Vaborbactam (RPX7009) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6326-32. doi: 10.1128/AAC.00568-16. Print 2016 Oct.
PubMed 27527080
Study at a glance
From the registry record, last updated by the sponsor on 24 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 of Intravenous RPX7009 in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT01751269
- Acronym / sponsor ID
- Rempex 402
- Conditions
- Healthy Volunteers, Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Dec 2012 (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 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 of RPX7009, administered alone, in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascending Single and Multiple dose of RPX7009 | Experimental | Drug: RPX7009Ascending Single and Multiple dose of RPX7009 |
| Normal Saline | Placebo comparator | Drug: PlaceboAscending Single and multiple dose of normal saline. |
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 (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
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.
- 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.
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)Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. | Drug | Ascending Single and Multiple dose of RPX7009 |
| PlaceboAlso: Normal salineTen (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. | Drug | Normal Saline |
Primary outcome
Safety from baseline through the end of the study.
Time frame: Study Day 1 to Day 13.
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.
1 secondary outcome
Composite of PK parameters RPX7009 & placebo following single dose administration.
Time frame: Study Day 1 to Day 12
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 24 Jul 2013.
- Derived from this study: PubMed 27527080Griffith DC, Loutit JS, Morgan EE, Durso S, Dudley MN. Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the beta-Lactamase Inhibitor Vaborbactam (RPX7009) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6326-32. doi: 10.1128/AAC.00568-16. Print 2016 Oct.
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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 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 24 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 through the end of the study. (time frame: Study Day 1 to Day 13.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751269, which also lists 1 linked publication.
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 24 Jul 2013.