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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730145

Enrollment

Registered

2008-08-08

Start date

2008-09-30

Completion date

2009-01-31

Last updated

2010-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics, Renal Dialysis

Keywords

pharmacokinetics, PD-0332334, hemodialysis, renal dialysis

Brief 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.

Detailed description

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

Interventions

DRUGPD-0332334

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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
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
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

Secondary

Measure	Time frame
Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.	0 to 8 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026