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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-04958242

Placebo

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring PF-04958242, multiple dose, safety, schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04958242

Placebo

Arm Description

Outcomes

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

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

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

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

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

Secondary Outcome Measures

Drug Effect Questionaire Liking scale

Digit Symbol Substitution Test

Columbia Suicide Severity Rating Scale

Full Information

NCT ID

NCT01511510

First Posted

July 19, 2011

Last Updated

November 19, 2019

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT01511510

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

PF-04958242, multiple dose, safety, schizophrenia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04958242

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-04958242

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PF-04958242

Intervention Description

PF-04958242 0.10 mg oral solution Q24 hours for 14 days

Intervention Type

Drug

Intervention Name(s)

PF-04958242

Intervention Description

PF-04958242 0.15 mg oral solution Q24 hours for 14 days

Intervention Type

Drug

Intervention Name(s)

PF-04958242

Intervention Description

PF-04958242 0.25 mg oral solution Q24 hours for 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo oral solution Q24 hours for 14 days

Primary Outcome Measure Information:

Title

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

Title

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

Time Frame

Day 4

Title

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

Time Frame

Day 7

Title

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

Title

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

Time Frame

Day 14-Day 15

Secondary Outcome Measure Information:

Title

Drug Effect Questionaire Liking scale

Time Frame

Day 14

Title

Digit Symbol Substitution Test

Time Frame

Day 14

Title

Columbia Suicide Severity Rating Scale

Time Frame

Day 0-Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1701007&StudyName=Study%20to%20Evaluate%20the%20Safety%2C%20Tolerability%20and%20Pharmacokinetics%20of%20Repeated%20Doses%20of%20PF-04958242%20in%20Healthy%20Volunteers%20

Description

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

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