Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
• Treatments: beta-Lactamase Inhibitors

Criteria

Inclusion Criteria:

1. Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.

2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).

3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examination) as deemed by the PI.

4. Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months prior to Day 1.

5. Voluntarily consent to participate in the study.

6. Sexually abstinent or agree to use two approved methods of contraception.

Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.

2. Positive urine drug/alcohol testing at screening or check-in (Day -1).

3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).

4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.

5. 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.

6. Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.

7. Plasma donation within 7 days prior to Day 1.

8. Participation in another investigational clinical trial within 30 days prior to Day 1.

9. Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).