Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
• Treatments: Biapenem; Thienamycins

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).