NCT00886093

Brief Summary

The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

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
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

Study Start

First participant enrolled

April 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
9 days 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

July 2, 2009

Status Verified

June 1, 2009

Enrollment Period

1 month

First QC Date

April 21, 2009

Last Update Submit

June 29, 2009

Conditions

Healthy

Keywords

pharmacokinetics, single dose, crossover, fed vs fasted state

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax).

    Up to 96 hours after drug administration

  • Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events.

    Up to 96 hours after drug administration

Secondary Outcomes (1)

  • No secondary outcomes

    No secondary outcomes

Study Arms (2)

Sequence 1

EXPERIMENTAL
Drug: PF-04447943

Sequence 2

EXPERIMENTAL
Drug: PF-04447943

Interventions

PF-04447943DRUG

35 mg tablet of PF-04447943 taken in the fed state in Period 1 followed a week later by administration of the same tablet and dose taken in the fasted state in Period 2

Sequence 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects, not of child bearing potential.
  • Age 18-55 inclusive
  • Total body weight \>50 kg.

You may not qualify if:

  • Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
  • History of orthostatic blood pressure changes or orthostatic symptoms
  • Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
  • Smoking more than 5 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Interventions

6-(4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl)-1-(tetrahydro-2H-pyran-4-yl)-1,5-dihydro-4H-pyrazolo(3,4-d)pyrimidin-4-one

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 2, 2009

Record last verified: 2009-06

Locations

US(1)