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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: PF-04958242; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01365338

B1701003

Details and patient eligibility

About

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.

Full description

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

Enrollment: 112 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive placebo as a single oral dose.

Treatment:

Drug: Placebo

Cohort 1

Experimental group

Description:

Participants will receive 0.075 milligrams (mg) of PF-04958242 as a single oral dose.

Treatment:

Drug: PF-04958242

Cohort 2

Experimental group

Description:

Participants will receive 0.15 mg of PF-04958242 as a single oral dose.

Treatment:

Drug: PF-04958242