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Scopolamine Challenge Study

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Placebo (Drug); Scopolamine (Drug); PF-05212377 (Drug); Scopolamine (Drug); PF-05212377 (Drug); scopolamine (Drug); PF-05212377 (Drug); scopolamine (Drug); Donepezil (Drug); Scopolamine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests.

Secondary outcome:

Detection Task (Speed; included in CogState Test Battery)

One Card Learning Task (Accuracy of performance; included in CogState Test Battery)

Continuous Paired Associate Learning Task (Number of errors; included in CogState Test Battery)

Bond-Lader Visual Analog Scales (included in CogState Test Battery)

Identification Task (Speed; included in CogState Test Battery)

Detailed description: Proof of mechanism

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Rennes 35000, France
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2011
Last updated: October 25, 2011

Page last updated: August 23, 2015

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