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

NCT01148771 | Completed Phase 4 Results

• 2 other identifiers: KUTI003194HEIISP ID#37935
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (2)

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

  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.

  5 or 30 minutes post start of infusion on Day 3

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

  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.

  0-24 hours after 3rd ertapenem dose

Secondary Outcomes (2)

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

  3 days

• Probability of Target Attainment (PTA)

  Simulated Steady-State Exposure

Study Arms (2)

Ertapenem 1 gram intravenous (IV) 5 minute bolus

EXPERIMENTAL

Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.

Drug: ertapenem

Ertapenem 1 gram IV 30 minute infusion

ACTIVE COMPARATOR

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

Interventions

ertapenem DRUG

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

Ertapenem 1 gram intravenous (IV) 5 minute bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (18 years of age or older)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Interventions

Ertapenem

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Joseph L. Kuti, Pharm.D. / Associate Director, Clinical and Economic Studies
• Organization: Center for Anti-Infective Research and Development, Hartford Hospital

jkuti@harthosp.org

860-545-3612

Study Officials

• Josepth L Kuti, PharmD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

• Dora E Wiskirchen, PharmD

  Hartford Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 11, 2012
• Results First Posted: May 11, 2012

Record last verified: 2012-04

Locations

US (1)