Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects
Primary Purpose
Healthy Volunteers, Bacterial Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RPX2003 (Biapenem)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- 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
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.
- Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
- History of seizures (e.g., epilepsy).
- 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.
- Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
- Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Sites / Locations
- Celerion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RPX2003 (Biapenem)
Normal Saline
Arm Description
Single and multiple dose of RPX2003 (Biapenem).
Single and multiple doses of normal saline.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Composite of PK parameters RPX2003 & placebo following single dose administration.
plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Composite of PK parameters RPX2003 & placebo following multiple dose administration.
plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Full Information
NCT ID
NCT01702649
First Posted
September 25, 2012
Last Updated
November 29, 2012
Sponsor
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
1. Study Identification
Unique Protocol Identification Number
NCT01702649
Brief Title
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects
Official Title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor 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 of biapenem, administered alone, in healthy adult subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Bacterial Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RPX2003 (Biapenem)
Arm Type
Experimental
Arm Description
Single and multiple dose of RPX2003 (Biapenem).
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Single and multiple doses of normal saline.
Intervention Type
Drug
Intervention Name(s)
RPX2003 (Biapenem)
Intervention Description
Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation.
Single dose followed by multiple dose, three times a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation.
Single dose followed by multiple dose, three times a day.
Primary Outcome Measure Information:
Title
Safety from baseline through the end of the study.
Description
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.
Time Frame
Study Day 1 to 13.
Secondary Outcome Measure Information:
Title
Composite of PK parameters RPX2003 & placebo following single dose administration.
Description
plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Time Frame
Part 1A Study Day 1 to 3.
Title
Composite of PK parameters RPX2003 & placebo following multiple dose administration.
Description
plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
Time Frame
Part 1B Day 4 to 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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.
Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
History of seizures (e.g., epilepsy).
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.
Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Loutit, MBChB
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Celerion
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects
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