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Completed

NCT Number: NCT01511510

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04958242

Drug

PF-04958242 0.05 mg oral solution Q24 hours for 14 days

Placebo

Drug

Placebo oral solution Q24 hours for 14 days

Primary outcomes

  1. 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

  2. Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4

    Time frame: Day 4

  3. Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7

    Time frame: Day 7

  4. 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

  5. Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14

    Time frame: Day 14-Day 15

Secondary outcomes

  1. Drug Effect Questionaire Liking scale

    Time frame: Day 14

  2. Digit Symbol Substitution Test

    Time frame: Day 14

  3. Columbia Suicide Severity Rating Scale

    Time frame: Day 0-Day 14

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 18, 2012
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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