Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.

NCT00959803 | Completed Phase 1

• 1 other identifier: B0401004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.

Conditions

Healthy

Keywords

Phase 1; Pharmacokinetics; Healthy Young Adult; Japanese; Healthy Elderly; Alzheimer disease

Outcome Measures

Primary Outcomes (4)

• AEs (spontaneous and solicited). Change from baseline in vital signs.

  Day 0 to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm)

• ECG and clinical safety laboratory endpoints, including a complete blood count, a full chemistry panel (including electrolytes and hepatic transaminases) and urinalysis.

  Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm)

• Pharmacokinetic (single): AUClast, Cmax, Tmax

  Day 1 to day 5

• Pharmacokinetic(multiple): AUCt, Cmax and Tmax on Days 1 and 7, and Ctrough on Days 2, 3, 4 and 7.

  Day 1 to day 11

Study Arms (2)

Single dose

EXPERIMENTAL

3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.

Drug: PF-04447943; Drug: Placebo

Multiple dose

EXPERIMENTAL

3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.

Drug: PF-04447943; Drug: Placebo

Interventions

PF-04447943 DRUG

3 mg solution, oral single dose.

Single dose

Placebo DRUG

Solution, oral single dose.

Single dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For young cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 18 and 55 years, inclusive.
• For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive.
• Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).

You may not qualify if:

• Pregnant or nursing women; women of childbearing potential.
• Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

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

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 17, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

US (1)