Scopolamine Challenge Study

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01213355

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo Drug: Scopolamine Drug: PF-05212377 Drug: Scopolamine Drug: PF-05212377 Drug: scopolamine Drug: PF-05212377 Drug: scopolamine Drug: Donepezil Drug: Scopolamine	Phase 1

Detailed Description

Proof of mechanism

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.