Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers, Bacterial Infections
In brief
RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.
Key facts
- Study ID
- NCT01702649
- Run by
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
- People needed
- 36
- Starts
- 2012-08-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2012-12-03
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Celerion — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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