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The purpose of this first in human (FIH) study is to investigate the safety, tolerability, pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects the body) of PF-04455242-01 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion. |
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| Placebo | Placebo Comparator | 2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04455242 | Drug | Powder-in Capsule (EP-PIC), will be used to administer doses from 0.5 mg up to and including 56 mg of a single rising dose over 3 treatment periods receiving two doses of PF-04455242 and one dose of placebo. A one-week (minimum) washout will separate each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay. | Daily | |
| Physical exam | Screening, End of Trial (EOT), and Follow Up (F/U) | |
| Clinical safety laboratory results | Screening, Day 0 (D0), D2, F/U | |
| 12-lead ECGs | Screening, D1, D2, F/U | |
| Maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the concentration-time curve (AUC) and terminal half-life (t1/2) . | 0 hr (predose) then 0.5-1 hr for the next 12 hrs postdose on D1, then 24, 36, 48, & 72 hrs postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Likert and Drug Effect Questionnaire (DEQ) questionnaires | 0 hr (predose) then 1, 2, 3, 4, 6 ,8, & 12 hrs (postdose) on D1, then 24 hrs (postdose) on D2 |
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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 | 06511-5473 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C568463 | 2-methyl-N-((2'-(pyrrolidin-1-ylsulfonyl)biphenyl-4-yl)methyl)propan-1-amine |
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| Placebo | Drug | PIC matching in appearance to PF-04455242 will be used to administer placebo. |
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