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Completed

NCT Number: NCT01148771

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertapenem

Drug

1 gram IV bolus every 24 hours (q24h) for 3 days

Primary outcomes

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

    Time frame: 5 or 30 minutes post start of infusion on Day 3

    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.

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

    Time frame: 0-24 hours after 3rd ertapenem dose

    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 outcomes

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

    Time frame: 3 days

    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.

  2. Probability of Target Attainment (PTA)

    Time frame: Simulated Steady-State Exposure

    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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
May 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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