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Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01511510
First received: July 19, 2011
Last updated: January 17, 2012
Last verified: January 2012

July 19, 2011
January 17, 2012
June 2011
November 2011   (final data collection date for primary outcome measure)
  • Composite of 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-Day 2 ] [ Designated as safety issue: No ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • 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-Day 18 ] [ Designated as safety issue: No ]
  • Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 [ Time Frame: Day 14-Day 15 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01511510 on ClinicalTrials.gov Archive Site
  • Drug Effect Questionaire Liking scale [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Digit Symbol Substitution Test [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale [ Time Frame: Day 0-Day 14 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers
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

This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Schizophrenia
  • Drug: PF-04958242
    PF-04958242 0.05 mg oral solution Q24 hours for 14 days
  • Drug: PF-04958242
    PF-04958242 0.10 mg oral solution Q24 hours for 14 days
  • Drug: PF-04958242
    PF-04958242 0.15 mg oral solution Q24 hours for 14 days
  • Drug: PF-04958242
    PF-04958242 0.25 mg oral solution Q24 hours for 14 days
  • Drug: Placebo
    Placebo oral solution Q24 hours for 14 days
  • Experimental: PF-04958242
    Interventions:
    • Drug: PF-04958242
    • Drug: PF-04958242
    • Drug: PF-04958242
    • Drug: PF-04958242
  • 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
39
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects of non-child bearing potential Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • History of seizures or of a condition with risk of seizures
  • Pregnant or nursing females, and females of child bearing potential
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01511510
B1701007
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

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