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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: PF-04958242
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 39
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04958242 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
Placebo Comparator: Placebo Drug: Placebo
Placebo oral solution Q24 hours for 14 days

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511510

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01511510     History of Changes
Other Study ID Numbers: B1701007
Study First Received: July 19, 2011
Last Updated: January 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-04958242
multiple dose
safety
schizophrenia

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

ClinicalTrials.gov processed this record on April 17, 2014