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Completed

NCT Number: NCT01213355

Scopolamine Challenge Study

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Rennes, 35000, France

About this study

Proof of mechanism

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Capsule, single dose, oral, 1 day

Scopolamine

Drug

injectable subcutaneous formulation, single dose, 1 day

PF-05212377

Drug

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

Donepezil

Drug

Tablet, 10mg, single dose, 1 day

Primary outcomes

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

    Time frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

Secondary outcomes

  1. Detection Task (Speed; included in CogState Test Battery)

    Time frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

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

    Time frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

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

    Time frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

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

    Time frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

  5. Identification Task (Speed; included in CogState Test Battery)

    Time frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2010
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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