NCT00832052

Brief Summary

Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in healthy elderly participants. Evaluate plasma drug levels and effects on cognition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
3 months 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

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

4 months

First QC Date

January 27, 2009

Last Update Submit

June 9, 2009

Conditions

HealthyElderly

Keywords

elderly, multi-dose, safety, efficacy

Outcome Measures

Primary Outcomes (5)

  • Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests

    For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.

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

    For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14

  • Maximum plasma concentration (Cmax)

    1 hour post dose day 4

  • Minimum plasma concentration ((Ctrough)

    For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13

  • Fraction of the total dose excreted in urine (Fe) and the renal clearance (CLR), and, if the data permit, half-life and the observed exposure accumulation ratio (Ro), and fluctuation index (Cmax: Cmin ratio) following multiple doses

    For cohorts 1-3, day 7; for cohort 4, day 14

Secondary Outcomes (1)

  • CogState Phase 1 Battery, to include Detect, Identify, One-Card Learning, Groton Maza Learning, Continuous Paired Associated Learning Test, and Composite Cognitive Score

    For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.

Study Arms (5)

Cohort 1

EXPERIMENTAL

Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).

Drug: PF-04447943

Cohort 2

EXPERIMENTAL

Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).

Drug: PF-04447943

Cohort 3a

EXPERIMENTAL

Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).

Drug: PF-04447943

Cohort 3b

EXPERIMENTAL

Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).

Drug: PF-04447943

Cohort 4

EXPERIMENTAL
Drug: PF-04447943

Interventions

PF-04447943DRUG

Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.

Cohort 1

Eligibility Criteria

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

You may qualify if:

  • Healthy male and/or female subjects.
  • Subjects must be in reasonably good health as determined by the investigator based on medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests.
  • Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis may be enrolled if deemed medically prudent by the investigator.
  • Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose.
  • Body Mass Index (BMI) between 18 to 30 kg/m2, inclusive; and a total body weight \>50 kg (110 lbs).
  • Creatinine clearance greater than 30 mL/min using the Cockcroft-Gault method.

You may not qualify if:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, or allergic disease.
  • Use of tobacco or any form of nicotine in the past 6 months.
  • Greater than 7 drinks of alcohol per week for women, and greater than 14 drinks of alcohol per week for men.

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

January 27, 2009

First Posted

January 29, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

US(1)