Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ascending Single and Multiple dose of RPX7009 Ascending Single and Multiple dose of RPX7009 |
Drug: RPX7009
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
Other Names:
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| Placebo Comparator: Normal Saline Ascending Single and multiple dose of normal saline. |
Drug: Placebo
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Safety from baseline through the end of the study. [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.
Secondary Outcome Measures
- Composite of PK parameters RPX7009 & placebo following single dose administration. [Study Day 1 to Day 12]
Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age
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Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
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Medically healthy with clinically insignificant screening results
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Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day
- Sexually abstinent or use acceptable methods of birth control
Exclusion Criteria:
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History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
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History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
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Documented hypersensitivity reaction or anaphylaxis to any medication.
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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.
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Plasma donation within 7 days prior to Day 1.
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Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CMAX | Adelaide | South Australia | Australia | 5000 |
Sponsors and Collaborators
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Investigators
- Study Director: Jefferey Loutit, MBChB, Sponsor GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Rempex 402