A study of the safety, tolerability and pharmacokinetics of single doses of PF-05180999 in healthy adults (clinicaltrials.gov) - Apr 10, 2012 - P1, N=29; Recruiting -> Completed; Completion date: Apr 2012 -> Dec 2011
Completion date • Trial completion • Schizophrenia
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This study has been completed.
First Received on August 24, 2011. Last Updated on April 10, 2012 History of Changes Sponsor: Pfizer
Information provided by (Responsible Party): Pfizer
ClinicalTrials.gov Identifier: NCT01429740
Purpose
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.
Condition
Schizophrenia
Intervention
Drug: PF-05180999
Drug: Placebo
Phase
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Placebo-Controlled, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-05180999 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects
Resource links provided by NLM:
MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
Composite (or profile) of Pharmacokinetics [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose on Day 1 and Day 1 ] [ Designated as safety issue: No ]
Enrollment: 29
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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