Scopolamine Challenge Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01213355
First received: September 16, 2010
Last updated: October 25, 2011
Last verified: October 2011

September 16, 2010
October 25, 2011
April 2011
August 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Groton Maze Learning Task (Total Errors). [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01213355 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Detection Task (Speed) and Identification Task (Speed) [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • One Card Learning Task (Accuracy of performance) [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Continuous Paired Associate Learning Task (Number of errors) [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Bond-Lader (alertness, contentment, and calmness) [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
  • Adverse events (spontaneous and solicited) [ Time Frame: 0-14 days ] [ Designated as safety issue: Yes ]
  • vital signs (blood pressure, pulse rate and body temperature, 12 lead ECGs intervals) [ Time Frame: 0-14 days ] [ Designated as safety issue: Yes ]
  • Clinical safety laboratory tests (hematology, fasting blood chemistry and urinalysis) [ Time Frame: 0-14 days ] [ Designated as safety issue: Yes ]
  • Physical examinations [ Time Frame: 0-14 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Cmax, tmax, AUC last, AUC (data permitting), t1/2 term (data permitting), CL/F (PF-05212377/donepezil; data permitting), and CL (scopolamine; data permitting) [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01213355
B2081009
No
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