NCT00730145

Brief Summary

  1. 1.Quantify how much PD-0332334 is removed from the blood with hemodialysis
  2. 2.Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
  3. 3.Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

4 months

First QC Date

August 6, 2008

Last Update Submit

February 16, 2010

Conditions

Renal DialysisPharmacokinetics

Keywords

pharmacokinetics, PD-0332334, hemodialysis, renal dialysis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

    0 to 8 days

Study Arms (1)

PD-0332334

EXPERIMENTAL
Drug: PD-0332334

Interventions

PD-0332334DRUG

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

Also known as: imagabalin
PD-0332334

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving regular hemodialysis
  • Male or female patients 18 to 65 years

You may not qualify if:

  • Severe heart failure
  • Renal transplant or renal allograft
  • Illicit drug use (with the exception of prescribed sedatives)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

Related Links

MeSH Terms

Interventions

imagabalin

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 8, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

US(1)