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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511510
• Other study ID #: B1701007
• Status: Completed
• Phase: Phase 1
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• PF-04958242
PF-04958242 0.05 mg oral solution Q24 hours for 14 days
• PF-04958242
PF-04958242 0.10 mg oral solution Q24 hours for 14 days
• PF-04958242
PF-04958242 0.15 mg oral solution Q24 hours for 14 days
• PF-04958242
PF-04958242 0.25 mg oral solution Q24 hours for 14 days
• Placebo
Placebo oral solution Q24 hours for 14 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4		Day 4
Primary	Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7		Day 7
Primary	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
Primary	Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14		Day 14-Day 15
Secondary	Drug Effect Questionaire Liking scale		Day 14
Secondary	Digit Symbol Substitution Test		Day 14
Secondary	Columbia Suicide Severity Rating Scale		Day 0-Day 14

External Links

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