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| Name | Class |
|---|---|
| Yale University | OTHER |
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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.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo as a single oral dose. |
|
| Cohort 1 | Experimental | Participants will receive 0.075 milligrams (mg) of PF-04958242 as a single oral dose. |
|
| Cohort 2 | Experimental | Participants will receive 0.15 mg of PF-04958242 as a single oral dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered as specified in the treatment arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Magnetic Resonance Imaging Data During Working Memory Task | 59 Minutes Post-dose | |
| Arterial Spin Labeling Data | 39 Minutes Post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New Haven | Connecticut | 06511 | United States | ||
| Research Site |
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| PF-04958242 |
| Drug |
Administered as specified in the treatment arm |
|
| Up to Day 11 |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
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