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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01238679 |
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Date of registration:
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02/11/2010 |
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Primary sponsor: |
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Public title:
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Multiple Dose Tolerance Study For PF-04958242
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Scientific title:
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A Phase I, Randomized, Subject And Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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20 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01238679 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- males or females of non-childbearing capacity
Exclusion Criteria:
- No medical, neurological or psychiatric illness
Age minimum:
21 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: PF-04958242 0.03 mg
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Drug: PF-04958242 0.05 mg
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Drug: Placebo
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Primary Outcome(s)
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Composite of PF-04958242 Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
[Time Frame: Day 1-2]
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Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
[Time Frame: Day 14-18]
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Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
[Time Frame: Day 4]
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Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
[Time Frame: Day 7]
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Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
[Time Frame: Day 14-15]
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Sheehan Suicidality Tracking Scale
[Time Frame: Days 0, 14, 24]
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Secondary Outcome(s)
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Digit symbol substitution test
[Time Frame: Days 0, 14]
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Drug Liking Questionaire
[Time Frame: Day 14]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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