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

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

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: PF-04958242
* Drug: PF-04958242
* Drug: PF-04958242
* Drug: PF-04958242
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04958242<br> | Drug: PF-04958242<br>* PF-04958242 0.05 mg oral solution Q24 hours for 14 days<br>Drug: PF-04958242<br>* PF-04958242 0.10 mg oral solution Q24 hours for 14 days<br>Drug: PF-04958242<br>* PF-04958242 0.15 mg oral solution Q24 hours for 14 days<br>Drug: PF-04958242<br>* PF-04958242 0.25 mg oral solution Q24 hours for 14 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo oral solution Q24 hours for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 urine Pharmacokinetics measured for 24 hours post-dose on Day 14 |  | Day 14-Day 15 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-04958242, multiple dose, safety, schizophrenia