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.

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00721422
First received: July 22, 2008
Last updated: February 16, 2010
Last verified: February 2010

July 22, 2008
February 16, 2010
August 2008
February 2009   (final data collection date for primary outcome measure)
  • maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast), [ Time Frame: 5 to 17 days depending on cohort ] [ Designated as safety issue: No ]
  • PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2), [ Time Frame: 5 to 17 days depending on cohort ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721422 on ClinicalTrials.gov Archive Site
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs [ Time Frame: 5 to 17 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.
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
  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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Renal Insufficiency
  • Pharmacokinetics
  • Drug: PD 0332334
    50 mg (two 25 mg capsules), single, oral dose
    Other Name: imagabalin
  • Drug: PD 0332334
    50 mg (two 25 mg capsules), single, oral dose
  • Experimental: Group 1-Normal
    Intervention: Drug: PD 0332334
  • Experimental: Group 2-Mild
    Intervention: Drug: PD 0332334
  • Experimental: Group 3-Moderate
    Intervention: Drug: PD 0332334
  • Experimental: Group 4-Severe
    Intervention: Drug: PD 0332334
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721422
A5361023
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP