Scopolamine Challenge Study

Study Overview
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Brief Summary
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It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.

Detailed Description
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Proof of mechanism

Official Title
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A Randomized, Double-Blind, Sponsor Unblinded, Placebo Controlled, 5-Way, Crossover Study To Evaluate The Effects Of Single Oral Administrations of PF-05212377 (SAM-760), A 5-HT6 Antagonist, On Scopolamine Induced Deficits In Psychomotor And Cognitive Function In Healthy Young Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: Scopolamine
* Drug: PF-05212377
* Drug: Scopolamine
* Drug: PF-05212377
* Drug: scopolamine
* Drug: PF-05212377
* Drug: scopolamine
* Drug: Donepezil
* Drug: Scopolamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects of non child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive. Body Mass index (BMI) of between 17.5 to 30.5 kg/m2 inclusive; and a total body weight greater than or equal to 50 kg (110 lbs). Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>placebo, plus scopolamine 0.5 mg | Drug: Placebo<br>* Capsule, single dose, oral, 1 day<br>Drug: Scopolamine<br>* injectable subcutaneous formulation, single dose, 1 day<br>|
| Experimental: PF-05212377 5 mg, plus scopolamine 0.5 mg;<br> | Drug: PF-05212377<br>* 5 mg, PF-05212377, capsule, single dose, 1 day<br>Drug: Scopolamine<br>* injectable subcutaneous formulation, single dose, 1 day<br>|
| Experimental: PF-05212377 20 mg, plus scopolamine 0.5 mg;<br> | Drug: PF-05212377<br>* 20 mg, capsule PF-05212377, single dose, 1 day<br>Drug: scopolamine<br>* injectable subcutaneous formulation, single dose, 1 day<br>|
| Experimental: PF-05212377 60 mg, plus scopolamine 0.5 mg;<br> | Drug: PF-05212377<br>* 60 mg PF-05212377, capsule, single dose, 1 day<br>Drug: scopolamine<br>* injectable sub cutaneous formulation, single dose, 1 day<br>|
| Active Comparator: donepezil 10 mg, plus scopolamine 0.5 mg.<br> | Drug: Donepezil<br>* Tablet, 10mg, single dose, 1 day<br>Drug: Scopolamine<br>* injectable sub cutaneous formulation, single dose, 1 day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests. |  | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection Task (Speed; included in CogState Test Battery) |  | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period | 
| One Card Learning Task (Accuracy of performance; included in CogState Test Battery) |  | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period | 
| Continuous Paired Associate Learning Task (Number of errors; included in CogState Test Battery) |  | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period | 
| Bond-Lader Visual Analog Scales (included in CogState Test Battery) |  | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period | 
| Identification Task (Speed; included in CogState Test Battery) |  | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, double-blind, placebo-controlled, 5-way crossover, single oral administrations of PF 05212377, scopolamine induced deficits in healthy subjects