Scopolamine Challenge Study

November 12, 2018 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Proof of mechanism

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Drug: Scopolamine
injectable sub cutaneous formulation, single dose, 1 day
Experimental: PF-05212377 5 mg, plus scopolamine 0.5 mg;
Drug: Scopolamine
injectable subcutaneous formulation, single dose, 1 day
Drug: Scopolamine
injectable sub cutaneous formulation, single dose, 1 day
Drug: PF-05212377
5 mg, PF-05212377, capsule, single dose, 1 day
Drug: PF-05212377
20 mg, capsule PF-05212377, single dose, 1 day
Drug: PF-05212377
60 mg PF-05212377, capsule, single dose, 1 day
Experimental: PF-05212377 20 mg, plus scopolamine 0.5 mg;
Drug: PF-05212377
5 mg, PF-05212377, capsule, single dose, 1 day
Drug: PF-05212377
20 mg, capsule PF-05212377, single dose, 1 day
Drug: PF-05212377
60 mg PF-05212377, capsule, single dose, 1 day
Drug: scopolamine
injectable subcutaneous formulation, single dose, 1 day
Drug: scopolamine
injectable sub cutaneous formulation, single dose, 1 day
Experimental: PF-05212377 60 mg, plus scopolamine 0.5 mg;
Drug: PF-05212377
5 mg, PF-05212377, capsule, single dose, 1 day
Drug: PF-05212377
20 mg, capsule PF-05212377, single dose, 1 day
Drug: PF-05212377
60 mg PF-05212377, capsule, single dose, 1 day
Drug: scopolamine
injectable subcutaneous formulation, 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: Scopolamine
injectable subcutaneous formulation, single dose, 1 day
Drug: Scopolamine
injectable sub cutaneous formulation, single dose, 1 day
Drug: Donepezil
Tablet, 10mg, single dose, 1 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
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)
Time Frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
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)
Time Frame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
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
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2081009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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