Study Examining The Effect Of Renal Impairment On Safety,... | NCT00472836

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

NCT00472836

Sponsor

Pfizer

Status

Completed

Last Update Posted

Aug 13, 2009Estimated

Enrollment

17Actual

Phase

Phase 1

Conditions

Obesity

Interventions

CP-945,598
CP-945,598

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

May 11, 2007

First Submission Date that Met QC Criteria

May 11, 2007

First Posted Date

May 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 11, 2009

Certification/Extension First Submitted that Passed QC Review

Aug 11, 2009

Certification/Extension First Posted Date

Aug 13, 2009Estimated

Last Update Submitted Date

Aug 11, 2009

Last Update Posted Date

Aug 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal renal function	Experimental		Drug: CP-945,598
Severe renal impairment	Experimental		Drug: CP-945,598

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CP-945,598	Drug	Administration of CP-945,598 in subjects with normal renal function.	Normal renal function

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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,		14 days
28, 35		14 days

Secondary Outcomes

Measure	Description	Time Frame
Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14		14 days
ECGs on Days 1,7 and 14		14 days
Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Anaheim	California	92801	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided