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The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. Pharmacodynamic interaction between PF-06372865 and lorazepam will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: | Experimental | Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. |
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| Cohort 2: | Experimental | Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. |
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| Cohort 3: | Experimental | Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. |
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| Cohort 4 (optional cohort): | Experimental | Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06372865 or Placebo | Drug | PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time | 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose | |
| Apparent Oral Clearance (CL/F) | 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose | |
| Apparent Volume of Distribution (Vz/F) | 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose | |
| Plasma Decay Half-Life (t1/2) | 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose | |
| Area Under the Curve From Time Zero to 24 hours | 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose | |
| Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy) | 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose | |
| Change in Body Sway | 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose |
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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 | Leiden | CL | 2333 | Netherlands |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-06372865 or Placebo | Drug | PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. |
|
| PF-06372865 or Placebo | Drug | PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. |
|
| PF-06372865 or Placebo or Lorazepam | Drug | Lorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation |
|
| Change in Smooth Pursuit | 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose |
| Change in Bond and Lader VAS | 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose |
| Change in Adaptive Tracking | 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose |
| Change in Visual Verbal Learning Test | 1 and 6 hours post dose |
| Change in Pharmaco-EEG | 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose |
| ID | Term |
|---|---|
| C000630159 | PF-06372865 |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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