A Study To Assess Effects Of PF-04958242 On Bold Functional Magnetic Resonance Imaging During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, Parallel Group Study to Assess Effects of PF-04958242 on Bold Functional MRI During Working Memory Activation and Arterial Spin Labeling at Rest in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365338
• Other study ID #: B1701003
• Status: Completed
• Phase: Phase 1
• Start date: June 24, 2011
• Est. completion date: December 14, 2012

Study information

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

Clinical Trial Summary

The primary objective of this study aims to determine whether the drug affects brain activity in healthy volunteers, either when the participants are performing a memory task, or when lying at rest. Subjects will undergo a brain scan under both of these conditions after a dose of either the study drug or a placebo is administered.The secondary objective is to evaluate the safety and tolerability of the four doses of PF-04958242 administered orally to healthy adult participants.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 14, 2012
• Est. primary completion date: December 14, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter squared (kg/m2);

• Total body weight >50 kilograms (kg) (110 pounds [lbs]);

Key Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);

• Positive urine drug screen;

• Pregnant or nursing females, and females of child bearing potential;

• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Administered as specified in the treatment arm
• PF-04958242
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	Research Site	New Haven	Connecticut
United States	Research Site	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Magnetic Resonance Imaging Data During Working Memory Task		59 Minutes Post-dose
Primary	Arterial Spin Labeling Data		39 Minutes Post-dose
Secondary	Number of Participants Experiencing Adverse Events and Serious Adverse Events	An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.	Up to Day 11