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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01148771
First received: June 18, 2010
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ertapenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose) [ Time Frame: 5 or 30 minutes post start of infusion on Day 3 ] [ Designated as safety issue: No ]
    Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.

  • Area Under the Curve From 48 to 72 Hours [AUC(48-72)] [ Time Frame: 0-24 hours after 3rd ertapenem dose ] [ Designated as safety issue: No ]
    AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    The following laboratory assessments will be make before and after participation in the study to determine if objective changes occurred: blood pressure, pulse rate, temperature, complete blood count with differential, platelet count, blood urea nitrogen, serum creatinine, liver function panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase], total bilirubin, and urinalysis with microscopy. Monitoring of other pathologic or unintended changes in structure (signs),or function (symptoms) of the body associated with participation in the study will occur.

  • Probability of Target Attainment (PTA) [ Time Frame: Simulated Steady-State Exposure ] [ Designated as safety issue: No ]
    After simulating 5000 patients receiving each dosing regimen, the probability of achieving free drug concentrations above an MIC of 0.25 mcg/mL and 0.5mcg/mL for at least 40% of the dosing interval (40% fT>MIC) is calculated at each MIC dilution.


Enrollment: 12
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertapenem 1 gram intravenous (IV) 5 minute bolus
Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.
Drug: ertapenem
1 gram IV bolus every 24 hours (q24h) for 3 days
Active Comparator: Ertapenem 1 gram IV 30 minute infusion
Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose).
Drug: ertapenem
1 gram 30 minute infusion q24h for 3 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148771

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Josepth L Kuti, PharmD Hartford Hospital
Study Director: Dora E Wiskirchen, PharmD Hartford Hospital
  More Information

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01148771     History of Changes
Other Study ID Numbers: KUTI003194HE, IISP ID#37935
Study First Received: June 18, 2010
Results First Received: March 15, 2012
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:
Pharmacokinetics
Safety

Additional relevant MeSH terms:
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014