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A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00759564
First received: September 23, 2008
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

This study will evaluate what effect renal dysfunction has on a drug that has an intravenous (CP-70,429) and an oral form (PF-03709270).


Condition Intervention Phase
Pneumonia
Drug: CP-70,429 and PF-03709270
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open-Label, 2-Way Crossover Study To Investigate The Pharmacokinetics, Safety And Tolerability Of IV CP-70429 And Oral PF-03709270 In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary pharmacokinetic endpoints to be evaluated for CP 70429 include Cmax, Tmax, AUClast, AUCinf, and CLr. [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of CP-70429 and PF-03709270 metabolites. [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]
  • Safety and tolerability will be assessed by adverse events, vital signs, 12 lead ECGs, physical examinations, laboratory safety tests (blood and urine). [ Time Frame: Screening -Day 4 ] [ Designated as safety issue: Yes ]
  • Secondary pharmacokinetic endpoints will include t1/2, time above MIC1.0 (duration of plasma concentrations of CP 70429 exceeding 1.0 μg/mL) and time above MIC0.5 (duration of plasma concentrations of CP 70429 exceeding 0.5 μg/mL). [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: November 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV CP-70,429 and cross over to PF-03709270 Drug: CP-70,429 and PF-03709270
Study Periods 1 and 2 will be separated by a minimum of 14 days. In Period 1, subjects will receive a single dose of CP-70429 (800 mg given as a 1.5 hour intravenous infusion), while in Period 2, subjects will receive a single oral dose of PF-03709270 (1000 mg).
Other Name: CP-70,429 - sulopenem

Detailed Description:

To evaluate the pharmacokinetics and safety.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet one of the following renal function categories:

  • Normal renal function (CLcr >80 mL/min).
  • Mild renal impairment (CLcr >50 and <80 mL/min).
  • Moderate renal impairment (CLcr >30 and <50 mL/min).
  • Severe renal impairment (CLcr <30 mL/min).

Exclusion Criteria:

Women who are pregnant or nursing or women who are of childbearing potential. History of clinically significant allergies, including seasonal allergies, and especially drug hypersensitivity including known allergies to components of the study drug formulation, penicillin, carbapenems and/or cephalosporin antibiotics (eg, amoxicillin, amoxicillin/clavulanate, ampicillin, cefadroxil, cephalexin, cefaclor and cefixime).

Subjects should not have evidence of a history of the following:

  • normal renal function: clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological or allergic disease.
  • renal impairment: any clinically significant (hepatic, cardiac or pulmonary or subjects with acute nephritic syndrome) diseases (except diabetes). Stable co-morbid disease where it is unlikely that the disease and medication will alter the outcome of the study will be allowed.
  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: NCT00759564

Locations
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00759564     History of Changes
Other Study ID Numbers: A8811009
Study First Received: September 23, 2008
Last Updated: April 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014