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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00472836

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

8.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: CP-945,598 Drug: CP-945,598	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal renal function	Drug: CP-945,598 Administration of CP-945,598 in subjects with normal renal function.
Experimental: Severe renal impairment	Drug: CP-945,598 Administration of CP-945,598 in subjects with severe renal impairment.

Arm

Intervention/Treatment

Experimental: Normal renal function

Drug: CP-945,598

Administration of CP-945,598 in subjects with normal renal function.

Experimental: Severe renal impairment

Drug: CP-945,598

Administration of CP-945,598 in subjects with severe renal impairment.

Outcome Measures

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, [14 days]
28, 35 [14 days]

Secondary Outcome Measures

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 [14 days]
Adverse event monitoring throughout duration of the study [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Anaheim	California	United States	92801
2	Pfizer Investigational Site	Miami	Florida	United States	33169

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00472836

Other Study ID Numbers:

A5351038

First Posted:

May 14, 2007

Last Update Posted:

Aug 13, 2009

Last Verified:

Nov 1, 2008

Study Results

No Results Posted as of Aug 13, 2009