A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

Pharmacokinetics Clinical Trial

Official title:

A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730145
• Other study ID #: A5361032
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2008
• Last updated: February 16, 2010
• Start date: September 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

1. Quantify how much PD-0332334 is removed from the blood with hemodialysis

2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.

3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.

Description:

Assess the elimination of PD-0332334 from the blood with hemodialysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients receiving regular hemodialysis

• Male or female patients 18 to 65 years

Exclusion Criteria:

• Severe heart failure

• Renal transplant or renal allograft

• Illicit drug use (with the exception of prescribed sedatives)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetics
• Renal Dialysis

Intervention

Drug:
• PD-0332334
A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis		0 to 8 days	No
Primary	Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis		0 to 8 days	No
Primary	Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast).		0 to 8 days	No
Secondary	Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.		0 to 8 days	Yes

External Links

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