Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects
Lead Sponsor:
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Conditions:
Healthy Volunteers
Bacterial Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
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 in...
Eligibility Criteria
Inclusion
- Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.
- 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 (e.g., laboratory profiles, medical histories, ECGs, physical examination) as deemed by the PI.
- Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months prior to Day 1.
- Voluntarily consent to participate in the study.
- Sexually abstinent or agree to use two approved methods of contraception.
Exclusion
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug/alcohol testing at screening or check-in (Day -1).
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
- 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.
- Plasma donation within 7 days prior to Day 1.
- Participation in another investigational clinical trial within 30 days prior to Day 1.
- Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01897779
Start Date
July 1 2013
End Date
February 1 2014
Last Update
April 29 2014
Active Locations (1)
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1
CMAX
Adelaide, South Australia, Australia, 5000