Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 11, 2007

Last Updated Date

April 23, 2009

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21, [ Time Frame: 14 days ] [ Designated as safety issue: No ]
28, 35 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, 35

Change History

Complete list of historical versions of study NCT00472836 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
ECGs on Days 1,7 and 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Adverse event monitoring throughout duration of the study [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Vital signs (Blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 ECGs on Days 1,7 and 14 Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 Adverse event monitoring throughout duration of the study

Descriptive Information

Brief Title ^†

Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

Official Title ^†

A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Severely Impaired And Normal Renal Function

Brief Summary

CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy control subjects.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Condition ^†

Obesity

Intervention ^†

Drug: CP-945,598

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2008

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Normal Subjects: 1.Healthy. 2.Matched for age (± 5 yrs), weight (± 10 kg), and gender ratio (± 2 subjects per gender).
Subjects with Renal Disease: 1. Severe impairment (Creatinine clearance <30 mL/min) 2. Stable renal disease:no change in the last 30 days. 3.

Stable dose of medication and/or treatment. 4. Reasonably well-controlled type 1 and type 2 diabetics

Exclusion Criteria:

All subjects: Non-prescribed use of drugs of abuse/ recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure parameters falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits
Normal subjects: Medically important health conditions; recent use of prescription or non-prescription medications.
Subjects with renal disease: Subjects requiring dialysis; certain chronic medical conditions; patients who have received renal transplant; severe and/or poorly controlled diabetes; Treatment with protocol-specified drugs that may alter the way the body absorbs or processes CP-945,598.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00472836

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.