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PD-0332334

Phase 1

Renal Dialysis | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Feb 17, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

PD-0332334 · 1 trial · 2 indications

Phase 1 1
NCT00730145A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular HemodialysisRenal Dialysis
COMPLETED8 Analytics
PHASE1COMPLETED
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
Renal Dialysis
NCT007301458
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Study Endpoints

Primary Endpoints

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 Endpoints

Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.
0 to 8 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
PD-0332334EXPERIMENTAL -

Interventions

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

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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)

Countries:United States
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Frequently asked questions about PD-0332334

What is PD 0332334 used for?

PD 0332334 is an investigational small molecule being developed for Generalized Anxiety Disorder and studied in patients receiving renal dialysis. It has been evaluated in Phase 1, Phase 2, and Phase 3 clinical trials, all of which are completed. The drug is not approved and remains in clinical development.

Who makes PD 0332334?

PD 0332334 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored multiple clinical trials of the drug, including a Phase 3 study in Generalized Anxiety Disorder.

What phase is PD 0332334 in?

PD 0332334 has completed Phase 3 clinical development. A 10-week Phase 3 study evaluated its efficacy and safety in Generalized Anxiety Disorder, and a Phase 2 trial compared it with alprazolam extended release and placebo. The drug is investigational and not FDA approved.

What clinical trials is PD 0332334 in?

PD 0332334 has completed three clinical trials: NCT00537615, a Phase 1 absorption, metabolism, and excretion study in healthy volunteers; NCT00542685, a Phase 3 efficacy and safety study in Generalized Anxiety Disorder; and NCT00730145, a Phase 1 study in hemodialysis patients. All trials are completed.

Is PD 0332334 the same as PD-0332334?

PD 0332334 and PD-0332334 refer to the same investigational drug. Clinical trial records use both spellings, with NCT00730145 titled 'PD-0332334' and other studies using 'PD 0332334'. Both names identify the same Pfizer compound.