Assessment Of The Effects Of Single Doses Of An Investigational Drug, Given Alone Or With Donepezil, On Scopolamine-Induced Changes In Memory And Learning In Healthy Adults

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NCT01345864

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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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.
Show details

- Healthy male or female volunteers; females must be of non-childbearing potential.

- Weight with normal limits for height.

- Willing to comply with study schedule and able to complete 2 practice sessions (pre-study) with computerized memory and learning/problem solving tests.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Positive urine drug screen; concurrent use of prescription or over-the-counter (OTC)
drugs or dietary supplements within 7 days or 5 half-lives prior to the first dose of
study medication.


- Use of medications with significant serotonergic, cholinergic or anticholinergic side
effects [SSRIs, pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin])
within 4 weeks of first dose of study drug.


- Glaucoma


- Abnormal electrocardiogram (ECG)


- Treatment with an investigational drug within 30 days of dosing.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Assessment Of The Effects Of Single Doses Of An Investigational Drug, Given Alone Or With Donepezil, On Scopolamine-Induced Changes In Memory And Learning In Healthy Adults
Official Title  ICMJE A Randomized, Double-Blind, Sponsor Unblinded, Placebo- And Positive- Controlled Study To Evaluate The Effects Of Single Oral Administrations Of PF-04995274, Alone Or In Combination With Donepezil, On Scopolamine-Induced Deficits In Psychomotor And Cognitive Function In Healthy Adults
Brief Summary This study is designed to look at the potential for an investigational drug (PF-04995274, under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to reverse changes in memory and learning/problem solving skills caused by co-administration of a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory and learning/problem solving skills that are similar to those seen in people with alzheimer's disease(AD).
Detailed Description Changes in sponsor's organizational strategy have led to the decision to terminate the study and therefore to not conduct the second cohort (Cohort B/arms 2 and 3) . This decision was not based on significant safety concerns. Date of termination (ie, the date the site was notified to stop study activities) was 12 Oct 2011.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Scopolamine + Donepezil Placebo + PF-04995274 Placebo
    Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
  • Drug: Scopolamine + Donepezil 5 mg + PF-04995274 Placebo
    Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 5 mg tablet orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
  • Drug: Scopolamine + Donepezil 10mg + PF-04995274 Placebo
    Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 10 mg (2 x 5 mg tablets) orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
  • Drug: Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg
    Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 0.25 mg oral liquid x 1 dose on Day 1
  • Drug: Scopolamine + Donepezil Placebo + PF-04995274 15 mg
    Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 15 mg oral liquid x 1 dose on day 1
Study Arms  ICMJE Cohort A
Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
Interventions:
  • Drug: Scopolamine + Donepezil Placebo + PF-04995274 Placebo
  • Drug: Scopolamine + Donepezil 5 mg + PF-04995274 Placebo
  • Drug: Scopolamine + Donepezil 10mg + PF-04995274 Placebo
  • Drug: Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg
  • Drug: Scopolamine + Donepezil Placebo + PF-04995274 15 mg
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 16, 2011)		88
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)		132
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female volunteers; females must be of non-childbearing potential.
  • Weight with normal limits for height.
  • Willing to comply with study schedule and able to complete 2 practice sessions (pre-study) with computerized memory and learning/problem solving tests.

Exclusion Criteria:

  • Positive urine drug screen; concurrent use of prescription or over-the-counter (OTC) drugs or dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication.
  • Use of medications with significant serotonergic, cholinergic or anticholinergic side effects [SSRIs, pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin]) within 4 weeks of first dose of study drug.
  • Glaucoma
  • Abnormal electrocardiogram (ECG)
  • Treatment with an investigational drug within 30 days of dosing.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01345864
Other Study ID Numbers  ICMJE B1661006
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 CenterPfizer
PRS Account Pfizer
Verification Date November 2011

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