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

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ClinicalTrials.gov Identifier: NCT01429740
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

August 24, 2011
September 7, 2011
April 12, 2012
August 2011
December 2011   (Final data collection date for primary outcome measure)
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 ]
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 14 of repeated dosing ]
Cmax, Tmax, AUClast, and if data permit, AUCinf, and t1/2
Complete list of historical versions of study NCT01429740 on ClinicalTrials.gov Archive Site
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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
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Schizophrenia
  • 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
  • Drug: Placebo
    Placebo oral solution or capsules
  • Experimental: PF-05180999
    Intervention: Drug: PF-05180999
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
36
December 2011
December 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01429740
B3441001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP