A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.

Pharmacokinetics Clinical Trial

Official title:

A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00721422
• Other study ID #: A5361023
• Status: Terminated
• Phase: Phase 1
• First received: July 22, 2008
• Last updated: February 16, 2010
• Start date: August 2008
• Est. completion date: February 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. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.

2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.

Description:

Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.

On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Healthy volunteers OR subjects with kidney impairment

Exclusion Criteria:

1. Receiving hemodialysis

2. clinically significant or unstable medical disease other than kidney disease

Study Design

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

Related Conditions & MeSH terms

• Pharmacokinetics
• Renal Insufficiency

Intervention

Drug:
• PD 0332334
50 mg (two 25 mg capsules), single, oral dose
• PD 0332334
50 mg (two 25 mg capsules), single, oral dose
• PD 0332334
50 mg (two 25 mg capsules), single, oral dose
• PD 0332334
50 mg (two 25 mg capsules), single, oral dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Cypress	California
United States	Pfizer Investigational Site	Miami	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), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)		1 day	No
Primary	amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)		5 days	No
Primary	PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),		5 to 17 days depending on cohort	No
Primary	PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),		5 to 17 days depending on cohort	No
Secondary	Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs		5 to 17 days	Yes

External Links

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