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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00721422

Enrollment

Registered

2008-07-24

Start date

2008-08-31

Completion date

2009-02-28

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

Renal Insufficiency, Pharmacokinetics

Keywords

Pharmacokinetics of PD 0332334 in subjects with renal insufficiency

Brief 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.

Detailed 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.

Interventions

DRUGPD 0332334

50 mg (two 25 mg capsules), single, oral dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)	1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)	5 days
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
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),	5 to 17 days depending on cohort

Secondary

Measure	Time frame
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs	5 to 17 days

Countries

United States

Outcome results

None listed

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