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Scopolamine

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 14, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

Scopolamine · 1 trial · 1 indication

Phase 1 1
NCT01213355Scopolamine Challenge StudyHealthy
COMPLETED38 Analytics
PHASE1COMPLETED
Scopolamine Challenge Study
Healthy
NCT0121335538
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Study Endpoints

Primary Endpoints

Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests.
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

Secondary Endpoints

Detection Task (Speed; included in CogState Test Battery)
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)
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)
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
PlaceboEXPERIMENTALplacebo, plus scopolamine 0.5 mg
PF-05212377 5 mg, plus scopolamine 0.5 mg;EXPERIMENTAL -
PF-05212377 20 mg, plus scopolamine 0.5 mg;EXPERIMENTAL -
PF-05212377 60 mg, plus scopolamine 0.5 mg;EXPERIMENTAL -
donepezil 10 mg, plus scopolamine 0.5 mg.ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGCapsule, single dose, oral, 1 day
ScopolamineDRUGinjectable subcutaneous formulation, single dose, 1 day
PF-05212377DRUG5 mg, PF-05212377, capsule, single dose, 1 day
DonepezilDRUGTablet, 10mg, single dose, 1 day
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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: ...

Countries:France
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Frequently asked questions about Scopolamine

What is Scopolamine used for?

Scopolamine is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial involving 38 participants. The drug is being evaluated for its effects in a challenge study, though it is not approved for any specific medical condition.

Who makes Scopolamine?

Scopolamine is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this small molecule drug, which is currently in Phase 1 development.

What phase is Scopolamine in?

Scopolamine is in Phase 1 clinical development. It has completed one Phase 1 trial, which enrolled 38 healthy volunteers. The drug is still investigational and has not been approved by regulatory authorities for any medical use.

What clinical trials is Scopolamine in?

Scopolamine has one completed clinical trial registered under NCT01213355, titled 'Scopolamine Challenge Study.' This Phase 1 trial enrolled 38 healthy volunteers in France, with participants aged 18 years and older. The study was randomized, double-blind, and actively controlled.

Is Scopolamine FDA approved?

Scopolamine is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT01213355, was a challenge study in healthy volunteers, but the drug has not received regulatory approval for any indication.