NCT01213355

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

September 16, 2010

Last Update Submit

November 12, 2018

Conditions

Healthy

Keywords

Randomizeddouble-blindplacebo-controlled5-way crossoversingle oral administrations of PF 05212377scopolamine induced deficits in healthy subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • Bond-Lader Visual Analog Scales (included in CogState Test Battery)

    Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

  • Identification Task (Speed; included in CogState Test Battery)

    Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period

Study Arms (5)

Placebo

EXPERIMENTAL

placebo, plus scopolamine 0.5 mg

Drug: PlaceboDrug: Scopolamine

PF-05212377 5 mg, plus scopolamine 0.5 mg;

EXPERIMENTAL
Drug: PF-05212377Drug: Scopolamine

PF-05212377 20 mg, plus scopolamine 0.5 mg;

EXPERIMENTAL
Drug: PF-05212377Drug: scopolamine

PF-05212377 60 mg, plus scopolamine 0.5 mg;

EXPERIMENTAL
Drug: PF-05212377Drug: scopolamine

donepezil 10 mg, plus scopolamine 0.5 mg.

ACTIVE COMPARATOR
Drug: DonepezilDrug: Scopolamine

Interventions

PlaceboDRUG

Capsule, single dose, oral, 1 day

Placebo
ScopolamineDRUG

injectable subcutaneous formulation, single dose, 1 day

Placebo
PF-05212377DRUG

5 mg, PF-05212377, capsule, single dose, 1 day

PF-05212377 5 mg, plus scopolamine 0.5 mg;
DonepezilDRUG

Tablet, 10mg, single dose, 1 day

donepezil 10 mg, plus scopolamine 0.5 mg.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Rennes, 35000, France

Location

Related Links

MeSH Terms

Interventions

ScopolamineSAM-760Donepezil

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingIndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2010

First Posted

October 4, 2010

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

FR(1)