Scopolamine Challenge Study
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01213355
First received: September 16, 2010
Last updated: October 25, 2011
Last verified: October 2011
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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:
Drug Information available for:
Scopolamine
Scopolamine hydrobromide
Butylscopolamine bromide
Donepezil hydrochloride
Donepezil
U.S. FDA Resources
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 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:
|
Scopolamine Butylscopolammonium Bromide Donepezil Mydriatics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Antagonists Cholinergic Antagonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Parasympatholytics Cholinesterase Inhibitors Enzyme Inhibitors Nootropic Agents |
ClinicalTrials.gov processed this record on May 16, 2013