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

NCT01365338 | Completed Phase 1

• 1 other identifier: B1701003
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Functional Magnetic Resonance Imaging Data During Working Memory Task

  59 Minutes Post-dose

• Arterial Spin Labeling Data

  39 Minutes Post-dose

Secondary Outcomes (1)

• Number of Participants Experiencing Adverse Events and Serious Adverse Events

  Up to Day 11

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo as a single oral dose.

Drug: Placebo

Cohort 1

EXPERIMENTAL

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

Drug: PF-04958242

Cohort 2

EXPERIMENTAL

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

Drug: PF-04958242

Interventions

Placebo DRUG

Administered as specified in the treatment arm

Placebo

PF-04958242 DRUG

Administered as specified in the treatment arm

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter squared (kg/m2);
• Total body weight \>50 kilograms (kg) (110 pounds \[lbs\]);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead
• Yale University: collaborator

Study Sites (2)

Research Site

New Haven, Connecticut, 06511, United States

Location

Research Site

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

PF-04958242

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: June 3, 2011
• Study Start: June 24, 2011
• Primary Completion: December 14, 2012
• Study Completion: December 14, 2012
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

US (2)