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

NCT01089738

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 3, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2010)
40
Estimated Study Completion Date  ICMJE April 25, 2011
Estimated Primary Completion Date April 25, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01089738
Other Study ID Numbers  ICMJE B1651003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP