HealthyPhase 1NCT01213355

Scopolamine Challenge Study

A Phase 1 study testing Scopolamine, PF-05212377 and Donepezil in people with Healthy, run by Pfizer at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Scopolamine, PF-05212377 and Donepezil
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteFrance
Study dates: Apr 2011to Aug 2011
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Pfizer Investigational Site
Rennes, 35000

Other trials in France

About this study

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

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

Read the detailed description

Proof of mechanism

Conditions: Healthy
Being tested: Placebo, Scopolamine, PF-05212377, Donepezil
Keywords: Randomized, double-blind, placebo-controlled, 5-way crossover, single oral administrations of PF 05212377, scopolamine induced deficits in healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Capsule, single dose, oral, 1 day
ScopolamineDrug
injectable subcutaneous formulation, single dose, 1 day
PF-05212377Drug
5 mg, PF-05212377, capsule, single dose, 1 day
ScopolamineDrug
injectable subcutaneous formulation, single dose, 1 day
PF-05212377Drug
20 mg, capsule PF-05212377, single dose, 1 day
scopolamineDrug
injectable subcutaneous formulation, single dose, 1 day
PF-05212377Drug
60 mg PF-05212377, capsule, single dose, 1 day
scopolamineDrug
injectable sub cutaneous formulation, single dose, 1 day
DonepezilDrug
Tablet, 10mg, single dose, 1 day
ScopolamineDrug
injectable sub cutaneous formulation, single dose, 1 day

Study groups in NCT01213355
Study group	Role	What they receive
Placebo	Experimental	placebo, plus scopolamine 0.5 mg Receives: Drug: Placebo; Drug: Scopolamine
PF-05212377 5 mg, plus scopolamine 0.5 mg;	Experimental	Not described Receives: Drug: PF-05212377; Drug: Scopolamine
PF-05212377 20 mg, plus scopolamine 0.5 mg;	Experimental	Not described Receives: Drug: PF-05212377; Drug: scopolamine
PF-05212377 60 mg, plus scopolamine 0.5 mg;	Experimental	Not described Receives: Drug: PF-05212377; Drug: scopolamine
donepezil 10 mg, plus scopolamine 0.5 mg.	Active comparator	Not described Receives: Drug: Donepezil; Drug: Scopolamine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Aug 2011

First posted4 Oct 2010 (estimated)
Study startApr 2011
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01213355
Sponsor's protocol ID: B2081009
Status last verified: Nov 2018
First submitted: 16 Sep 2010
Last updated: 14 Nov 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01213355
Acronym / sponsor ID: B2081009
Conditions: Healthy
Keywords: Randomized, double-blind, placebo-controlled, 5-way crossover, single oral administrations of PF 05212377, scopolamine induced deficits in healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 4 Oct 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Proof of mechanism

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo	Experimental	Drug: Placebo, Drug: Scopolamineplacebo, plus scopolamine 0.5 mg
PF-05212377 5 mg, plus scopolamine 0.5 mg;	Experimental	Drug: PF-05212377, Drug: Scopolamine
PF-05212377 20 mg, plus scopolamine 0.5 mg;	Experimental	Drug: PF-05212377, Drug: scopolamine
PF-05212377 60 mg, plus scopolamine 0.5 mg;	Experimental	Drug: PF-05212377, Drug: scopolamine
donepezil 10 mg, plus scopolamine 0.5 mg.	Active comparator	Drug: Donepezil, Drug: Scopolamine

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboCapsule, single dose, oral, 1 day	Drug	Placebo
Scopolamineinjectable subcutaneous formulation, single dose, 1 day	Drug	Placebo
PF-052123775 mg, PF-05212377, capsule, single dose, 1 day	Drug	PF-05212377 5 mg, plus scopolamine 0.5 mg;
Scopolamineinjectable subcutaneous formulation, single dose, 1 day	Drug	PF-05212377 5 mg, plus scopolamine 0.5 mg;
PF-0521237720 mg, capsule PF-05212377, single dose, 1 day	Drug	PF-05212377 20 mg, plus scopolamine 0.5 mg;
scopolamineinjectable subcutaneous formulation, single dose, 1 day	Drug	PF-05212377 20 mg, plus scopolamine 0.5 mg;
PF-0521237760 mg PF-05212377, capsule, single dose, 1 day	Drug	PF-05212377 60 mg, plus scopolamine 0.5 mg;
scopolamineinjectable sub cutaneous formulation, single dose, 1 day	Drug	PF-05212377 60 mg, plus scopolamine 0.5 mg;
DonepezilTablet, 10mg, single dose, 1 day	Drug	donepezil 10 mg, plus scopolamine 0.5 mg.
Scopolamineinjectable sub cutaneous formulation, single dose, 1 day	Drug	donepezil 10 mg, plus scopolamine 0.5 mg.

Primary outcome

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

5 secondary outcomes

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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Scopolamine, PF-05212377 and Donepezil in people with Healthy, run by Pfizer at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01213355.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.