NCT00736528

Brief Summary

To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.

Trial Health

57
Monitor

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 Aug 2008

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

Study Start

First participant enrolled

August 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 25, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

August 15, 2008

Last Update Submit

February 23, 2009

Conditions

HealthyElderly

Keywords

safety, tolerability, pharmacokinetics, cognition

Outcome Measures

Primary Outcomes (2)

  • Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints

    14 days

  • Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax

    14 days

Secondary Outcomes (1)

  • Changes in cognition from baseline

    14 days

Study Arms (4)

PF-04447943 05 mg dose

EXPERIMENTAL
Drug: PF-04447943

PF-04447943 15 mg dose

EXPERIMENTAL
Drug: PF-04447943

PF-04447943 45 mg dose

EXPERIMENTAL
Drug: PF-04447943

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04447943DRUG

05 mg BID for 14 days

PF-04447943 05 mg dose
PlaceboDRUG

Placebo for 14 days

Placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy
  • Elderly

You may not qualify if:

  • Evidence or history of clinically significant unstable disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Gainesville, Florida, 32608, 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

August 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 25, 2009

Record last verified: 2009-02

Locations

US(1)