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Completed

NCT Number: NCT00959803

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

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.

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Key information

Conditions

Healthy Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

PF-04447943

Drug

3 mg solution, oral single dose.

Placebo

Drug

Solution, oral single dose.

Primary outcomes

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

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

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

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

  3. Pharmacokinetic (single): AUClast, Cmax, Tmax

    Time frame: Day 1 to day 5

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

    Time frame: Day 1 to day 11

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Investigator- And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04447943 After Administration Of Single Oral Doses To Healthy Young Adult Japanese Subjects And Multiple Oral Doses To Healthy Elderly Japanese Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 17, 2009
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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