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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511510

Enrollment

Registered

2012-01-18

Start date

2011-06-30

Completion date

2011-11-30

Last updated

2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

PF-04958242, multiple dose, safety, schizophrenia

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.

Interventions

DRUGPF-04958242

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

DRUGPlacebo

Placebo oral solution Q24 hours for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14	Day 14-Day 15
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4	Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7	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	Day 14-Day 18
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1	Day 1-Day 2

Secondary

Measure	Time frame
Digit Symbol Substitution Test	Day 14
Columbia Suicide Severity Rating Scale	Day 0-Day 14
Drug Effect Questionaire Liking scale	Day 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026