A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults
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
1 other identifier
interventional
29
1 country
1
Brief Summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Aug 2011
Shorter than P25 for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 12, 2012
April 1, 2012
4 months
August 24, 2011
April 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite (or profile) of Pharmacokinetics
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
Study Arms (2)
PF-05180999
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Ascending single oral doses of 0.1, 0.3, 1.0, 3, 10, 30, 100, and 250 mg oral solution or capsules
Eligibility Criteria
You may qualify if:
- male or female of non-childbearing potential,
You may not qualify if:
- Evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2011
First Posted
September 7, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
April 12, 2012
Record last verified: 2012-04