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Trial record 1 of 1 for:    NCT01213355
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Scopolamine Challenge Study

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ClinicalTrials.gov Identifier: NCT01213355
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 16, 2010
First Posted Date  ICMJE October 4, 2010
Last Update Posted Date November 14, 2018
Study Start Date  ICMJE April 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2010)
Groton Maze Learning Task (Total Errors). [ Time Frame: 0-12 hours ]
Change History Complete list of historical versions of study NCT01213355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2010)
  • Detection Task (Speed) and Identification Task (Speed) [ Time Frame: 0-12 hours ]
  • One Card Learning Task (Accuracy of performance) [ Time Frame: 0-12 hours ]
  • Continuous Paired Associate Learning Task (Number of errors) [ Time Frame: 0-12 hours ]
  • Bond-Lader (alertness, contentment, and calmness) [ Time Frame: 0-12 hours ]
  • Adverse events (spontaneous and solicited) [ Time Frame: 0-14 days ]
  • vital signs (blood pressure, pulse rate and body temperature, 12 lead ECGs intervals) [ Time Frame: 0-14 days ]
  • Clinical safety laboratory tests (hematology, fasting blood chemistry and urinalysis) [ Time Frame: 0-14 days ]
  • Physical examinations [ Time Frame: 0-14 days ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Scopolamine Challenge Study
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2011)
38
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2010)
35
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01213355
Other Study ID Numbers  ICMJE B2081009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP