Scopolamine Challenge Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: PF-05212377; Drug: Donepezil; Drug: scopolamine

• Registration Number: NCT01213355
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Proof of mechanism

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-04
• Study Start: 2011-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo, plus scopolamine 0.5 mg
Placebo	scopolamine	placebo, plus scopolamine 0.5 mg
PF-05212377 5 mg, plus scopolamine 0.5 mg;	PF-05212377	-
PF-05212377 20 mg, plus scopolamine 0.5 mg;	PF-05212377	-
PF-05212377 5 mg, plus scopolamine 0.5 mg;	scopolamine	-
PF-05212377 20 mg, plus scopolamine 0.5 mg;	scopolamine	-
PF-05212377 60 mg, plus scopolamine 0.5 mg;	scopolamine	-
donepezil 10 mg, plus scopolamine 0.5 mg.	scopolamine	-
donepezil 10 mg, plus scopolamine 0.5 mg.	Donepezil	-
PF-05212377 60 mg, plus scopolamine 0.5 mg;	PF-05212377	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Detection Task (Speed; 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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Rennes, France