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A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01429740
First received: August 24, 2011
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  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 Intervention Phase
Schizophrenia
 Drug: PF-05180999
Drug: Placebo
 Phase 1

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)
Arms Assigned Interventions
Experimental: PF-05180999 Drug: PF-05180999
Ascending single oral doses of 0.1, 0.3, 1.0, 3, 10, 30, 100, and 250 mg oral solution or capsules
Placebo Comparator: Placebo Drug: Placebo
Placebo oral solution or capsules

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

male or female of non-childbearing potential,

Exclusion Criteria:

Evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429740

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01429740     History of Changes
Other Study ID Numbers: B3441001
Study First Received: August 24, 2011
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF 05180999
safety
pharmacokinetics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013