NCT00857571

Brief Summary

The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

1 month

First QC Date

March 5, 2009

Last Update Submit

December 5, 2018

Conditions

Keywords

Dose Response Bioavailability Study

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics: Cmax, AUCinf

    June - July 2009

Secondary Outcomes (1)

  • Tmax, Tlag, AUClast, AUCt, t½, Frel.

    June-July 2009

Study Arms (2)

Suspension

EXPERIMENTAL

PF-02413873 suspension

Drug: 150 mg SuspensionDrug: 30 mg SuspensionDrug: 400 mg SuspensionDrug: 5 mg SuspensionDrug: 750 mg Suspension

Tablet

EXPERIMENTAL

PF-02413873 Phase 2 Tablets

Drug: 150 mg TabletDrug: 30 mg TabletDrug: 400 mg TabletDrug: 5 mg TabletDrug: 750 mg Tablet

Interventions

Single oral dose of 150 mg of PF-02413873 suspension

Suspension

Single oral dose of 30 mg of PF-02413873 suspension

Suspension

Single oral dose of 400 mg of PF-02413873 suspension

Suspension

Single oral dose of 5 mg of PF-02413873 suspension

Suspension

Single oral dose of 750 mg of PF-02413873 suspension

Suspension

Single oral dose of 150 mg of PF-02413873 tablets

Tablet

Single oral dose of 30 mg of PF-02413873 tablets

Tablet

Single oral dose of 400 mg of PF-02413873 tablets

Tablet

Single oral dose of 5 mg of PF-02413873 tablets

Tablet

Single oral dose of 750 mg of PF-02413873 tablets

Tablet

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female volunteers.
  • Female volunteers have to be of non-childbearing potential

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

SuspensionsTablets

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 7, 2018

Record last verified: 2018-12

Locations