Scopolamine Challenge Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01213355

Enrollment

Registered

2010-10-04

Start date

2011-04-30

Completion date

2011-08-31

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Randomized, double-blind, placebo-controlled, 5-way crossover, single oral administrations of PF 05212377, scopolamine induced deficits in healthy subjects

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

Interventions

DRUGPlacebo

Capsule, single dose, oral, 1 day

DRUGScopolamine

injectable subcutaneous formulation, single dose, 1 day

DRUGPF-05212377

5 mg, PF-05212377, capsule, single dose, 1 day

DRUGscopolamine

injectable subcutaneous formulation, single dose, 1 day

DRUGDonepezil

Tablet, 10mg, single dose, 1 day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026