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See termination reason in detailed description.
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The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.
A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.
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 1 | Experimental | Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days. |
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| Cohort 2 | Experimental | Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days. |
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| Cohort 3 | Experimental | Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days. |
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| Cohort 4 | Experimental | Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days. |
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| Cohort 5 | Experimental | Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days. |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04958242 | Drug | Administered as specified in the treatment arm |
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| 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 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 up to Day 23 |
| Maximum Plasma Drug Concentration (Cmax) for Single Dose | Day 1 and at multiple time points up to Day 17 | |
| Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose | Day 1 and at multiple time points up to Day 17 | |
| Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose | Day 1 and at multiple time points up to Day 17 | |
| Maximum Observed Plasma Concentration (Cmax) for Steady State | Day 1 and at multiple time points up to Day 17 | |
| Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State | Day 1 and at multiple time points up to Day 17 | |
| Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State | Day 1 and at multiple time points up to Day 17 | |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State |
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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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Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.
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| Matching Placebo | Placebo Comparator | Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days. |
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| Placebo | Drug | Administered as specified in the treatment arm |
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| Day 1 and at multiple time points up to Day 17 |
| Elimination Half-Life (t1/2) for Steady State | Day 1 and at multiple time points up to Day 17 |
| Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State | Day 1 and at multiple time points up to Day 17 |
| Percent of Dose Eliminated in Urine Unchanged (Ae%) | Day 14 |
| Amount of PF-04958242 Eliminated in Urine Unchanged (Ae) | Day 14 |
| Renal Clearance (CLr) | Day 14 |
| Time to Reach Maximum Plasma Concentration (Tmax) for Steady State | Day 1 and at multiple time points up to Day 17 |