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NCT Number: NCT00730145

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

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.

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Key information

Conditions

Renal Dialysis Pharmacokinetics

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Orlando, Florida, 32809, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PD-0332334

Drug

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

Other names: imagabalin

Primary outcomes

  1. 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

    Time frame: 0 to 8 days

  2. 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

    Time frame: 0 to 8 days

  3. 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).

    Time frame: 0 to 8 days

Secondary outcomes

  1. Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.

    Time frame: 0 to 8 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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