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Scopolamine Challenge Study

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Rennes, , 35000 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01213355
Pfizer
Completed
Scopolamine Challenge Study

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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
It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.
Proof of mechanism
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy
  • Drug: Placebo
    Capsule, single dose, oral, 1 day
  • Drug: Scopolamine
    injectable subcutaneous 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: scopolamine
    injectable subcutaneous formulation, single dose, 1 day
  • Drug: PF-05212377
    60 mg PF-05212377, capsule, single dose, 1 day
  • Drug: scopolamine
    injectable sub cutaneous formulation, single dose, 1 day
  • Drug: Donepezil
    Tablet, 10mg, single dose, 1 day
  • Drug: Scopolamine
    injectable sub cutaneous formulation, single dose, 1 day
  • No Intervention: Placebo
    placebo, plus scopolamine 0.5 mg
    Interventions:
    • Drug: Placebo
    • Drug: Scopolamine
  • Experimental: PF-05212377 5 mg, plus scopolamine 0.5 mg;
    Interventions:
    • Drug: PF-05212377
    • Drug: Scopolamine
  • Experimental: PF-05212377 20 mg, plus scopolamine 0.5 mg;
    Interventions:
    • Drug: PF-05212377
    • Drug: scopolamine
  • Experimental: PF-05212377 60 mg, plus scopolamine 0.5 mg;
    Interventions:
    • Drug: PF-05212377
    • Drug: scopolamine
  • Active Comparator: donepezil 10 mg, plus scopolamine 0.5 mg.
    Interventions:
    • Drug: Donepezil
    • Drug: Scopolamine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
August 2011
August 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01213355
B2081009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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