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The purpose of this study in healthy people is to investigate safety, toleration and time course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162 will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04895162 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04895162 | Drug | Tablets, 300 mg, single, 1 day |
| |
| PF-04895162 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | up to 12 h post dose for Days 1, 7 and 14 | |
| Time of maximum concentration (Tmax) | up to 12 h post dose for Days 1, 7 and 14 | |
| Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf) | up to 12 h post dose for Days 1, 7 and 14 | |
| Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast) | up to 12 h post dose for Days 1, 7 and 14 | |
| Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24) | up to 12 h post dose for Days 1, 7 and 14 | |
| AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) | up to 12 h post dose for Days 1, 7 and 14 | |
| t1/2 = Terminal Elimination half life | up to 12 h post dose for Days 1, 7 and 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31624633 | Derived | Generaux G, Lakhani VV, Yang Y, Nadanaciva S, Qiu L, Riccardi K, Di L, Howell BA, Siler SQ, Watkins PB, Barton HA, Aleo MD, Shoda LKM. Quantitative systems toxicology (QST) reproduces species differences in PF-04895162 liver safety due to combined mitochondrial and bile acid toxicity. Pharmacol Res Perspect. 2019 Oct 9;7(6):e00523. doi: 10.1002/prp2.523. eCollection 2019 Dec. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000630727 | PF-04895162 |
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| Drug |
Tablets, 300 mg, twice a day, 14 days |
|
| PF-04895162 | Drug | Tablets, to be decided, twice a day, 14 days |
|
| Placebo | Drug | Tablets, twice a day, 14 days |
|