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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Placebo
Drug: Scopolamine
Drug: PF-05212377
Drug: scopolamine
Drug: Donepezil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 38
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo
placebo, plus scopolamine 0.5 mg
Drug: Placebo
Capsule, single dose, oral, 1 day
Drug: Scopolamine
injectable subcutaneous formulation, single dose, 1 day
Experimental: PF-05212377 5 mg, plus scopolamine 0.5 mg; Drug: PF-05212377
5 mg, PF-05212377, capsule, single dose, 1 day
Drug: Scopolamine
injectable subcutaneous formulation, single dose, 1 day
Experimental: PF-05212377 20 mg, plus scopolamine 0.5 mg; Drug: PF-05212377
20 mg, capsule PF-05212377, single dose, 1 day
Drug: scopolamine
injectable subcutaneous formulation, single dose, 1 day
Experimental: PF-05212377 60 mg, plus scopolamine 0.5 mg; Drug: PF-05212377
60 mg PF-05212377, capsule, 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: Donepezil
Tablet, 10mg, single dose, 1 day
Drug: Scopolamine
injectable sub cutaneous formulation, single dose, 1 day

Detailed Description:

Proof of mechanism

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213355

Locations
France
Pfizer Investigational Site
Rennes, France, 35000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01213355     History of Changes
Other Study ID Numbers: B2081009
Study First Received: September 16, 2010
Last Updated: October 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Randomized
double-blind
placebo-controlled
5-way crossover
single oral administrations of PF 05212377
scopolamine induced deficits in healthy subjects

Additional relevant MeSH terms:
Butylscopolammonium Bromide
Donepezil
Scopolamine Hydrobromide
Adjuvants, Anesthesia
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Nootropic Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014