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A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals

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NCT01089738

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy volunteer aged 65-80 years old

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

- Total body weight >50 kg (110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Subjects with symptoms or signs of adrenal insufficiency.

- Subjects with clinically significant ocular lens abnormalities as detected by the
investigator based on the findings of a slit lamp examination performed by an
ophthalmologist.

NCT01089738
Pfizer
Withdrawn
A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals

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A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of PF-03382792 In Healthy Elderly Subjects
This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.
To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Healthy
  • Drug: PF-03382792 0.5mg
    0.5 mg PF-03382792, qd, for 14 days or placebo
  • Drug: PF-03382792 1.5 mg
    1.5 mg PF-03382792, qd, for 14 days or placebo
  • Drug: PF-03382792 5 mg
    5 mg PF-03382792, qd, for 14 days or placebo
  • Drug: PF-03382792 15 mg
    15 mg PF-03382792, qd, for 14 days or placebo
Experimental: Dosing
Ascending Doses
Interventions:
  • Drug: PF-03382792 0.5mg
  • Drug: PF-03382792 1.5 mg
  • Drug: PF-03382792 5 mg
  • Drug: PF-03382792 15 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer aged 65-80 years old
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
  • Total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subjects with symptoms or signs of adrenal insufficiency.
  • Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.
Sexes Eligible for Study: All
65 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01089738
B1651003
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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