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

NCT00472836 | Completed Phase 1

• 1 other identifier: A5351038
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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 (4)

• 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

Study Arms (2)

Normal renal function

EXPERIMENTAL

Drug: CP-945,598

Severe renal impairment

EXPERIMENTAL

Drug: CP-945,598

Interventions

CP-945,598 DRUG

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

Normal renal function

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Related Links

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

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 14, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 13, 2009

Record last verified: 2008-11

Locations

US (2)