A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
NCT01089738
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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).
- 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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| 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 |
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| Study Arms ICMJE | Experimental: Dosing
Ascending Doses Interventions:
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| 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| Recruitment Status ICMJE | Withdrawn | ||||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 | 0 | ||||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| 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 | |||||