Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

Condition(s) targeted: Healthy

Intervention: ertapenem (Drug); ertapenem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hartford Hospital

Official(s) and/or principal investigator(s):
Josepth L Kuti, PharmD, Principal Investigator, Affiliation: Hartford Hospital
Dora E Wiskirchen, PharmD, Study Director, Affiliation: Hartford Hospital

The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.

Official title: Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)

Area Under the Curve From 48 to 72 Hours [AUC(48-72)]

Secondary outcome:

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Probability of Target Attainment (PTA)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy adults (18 years of age or older)

Exclusion Criteria:

- Ertapenem or other beta-lactam allergy

- Pregnant or breast feeding females

- Body Mass Index (BMI) greater than or equal to 30

- Abnormal lab values at baseline

- Hypertension

- Significant medical abnormality

- Regular alcohol consumption

- Significant nicotine use

Hartford Hospital, Hartford, Connecticut 06102, United States

Starting date: August 2010
Last updated: April 13, 2012