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The primary objective of this study will evaluate the safety and tolerability of single, escalating doses of PF-04958242 administered orally to healthy adult participants. This study will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after single escalating 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 |
|---|---|---|---|
| Cohort A | Experimental | Period 1: Participants received 0.01 milligrams (mg) of PF-04958242 or matching placebo, once, orally. Period 2: Participants received 0.03 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 0.1 mg of PF-04958242 or matching placebo, once, orally. |
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| Cohort B | Experimental | Period 1: Participants received 0.3 mg of PF-04958242 or matching placebo, once, orally (fasted). Period 2: Participants received 0.6 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 1.0 mg of PF-04958242 or matching placebo, once, orally (fed). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04958242 | Drug | Administered as specified in the treatment arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An adverse event is any untoward medical occurrence in a clinical investigation subject 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. | Baseline to Day 4 |
| Maximum Observed Plasma Concentration (Cmax) | Day 1 and at multiple time points up to Day 4 | |
| Time to Reach Cmax (Tmax) | Day 1 and at multiple time points up to Day 4 | |
| Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) | Day 1 and at multiple time points up to Day 4 | |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) | Day 1 and at multiple time points up to Day 4 | |
| Apparent Total Plasma Clearance (CL/F) | Day 1 and at multiple time points up to Day 4 | |
| Apparent Terminal Elimination Half-life (t½) | Day 1 and at multiple time points up to Day 4 | |
| Area Under the Plasma Drug Concentration-Time Curve up to the Last Quantifiable Time-Point (AUC0-last) | Day 1 and at multiple time points up to Day 4 |
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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 | Singapore | 188770 | Singapore |
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| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
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| Placebo |
| Drug |
Administered as specified in the treatment arm |
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