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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: PF-04958242; Drug: Placebo

• Registration Number: NCT01511510
• Lead Sponsor: Biogen

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-19
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04958242	PF-04958242	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4	Day 4
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14	Day 14-Day 15

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States