A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults

A Phase 1 study testing PF-05180999 in people with Schizophrenia, run by Pfizer at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia
What is being tested?: PF-05180999
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Dec 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

male or female of non-childbearing potential,

Who cannot join

Evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A Phase 1, Placebo-Controlled, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-05180999 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.

Conditions: Schizophrenia
Being tested: PF-05180999, Placebo
Keywords: PF 05180999, safety, pharmacokinetics
Medical subject headings: Schizophrenia

What participants receive

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

PF-05180999Drug
Ascending single oral doses of 0.1, 0.3, 1.0, 3, 10, 30, 100, and 250 mg oral solution or capsules
PlaceboDrug
Placebo oral solution or capsules

Study groups in NCT01429740
Study group	Role	What they receive
PF-05180999	Experimental	Not described Receives: Drug: PF-05180999
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Composite (or profile) of Pharmacokinetics
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose on Day 1 and Day 1

Timeline

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

Aug 2011Dec 2011

First posted7 Sep 2011 (estimated)
Study startAug 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01429740
Sponsor's protocol ID: B3441001
Status last verified: Apr 2012
First submitted: 24 Aug 2011
Last updated: 12 Apr 2012
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?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
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Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
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Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Placebo-Controlled, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-05180999 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01429740
Acronym / sponsor ID: B3441001
Conditions: Schizophrenia
Keywords: PF 05180999, safety, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 7 Sep 2011 (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.

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PF-05180999	Experimental	Drug: PF-05180999
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (1 listed)

male or female of non-childbearing potential,

Key exclusion criteria (1 listed)

Evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption

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
PF-05180999Ascending single oral doses of 0.1, 0.3, 1.0, 3, 10, 30, 100, and 250 mg oral solution or capsules	Drug	PF-05180999
PlaceboPlacebo oral solution or capsules	Drug	Placebo

Primary outcome

Composite (or profile) of Pharmacokinetics
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose on Day 1 and Day 1

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 12 Apr 2012.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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 PF-05180999 in people with Schizophrenia, run by Pfizer at 1 site in United States.

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 1 inclusion and 1 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 12 Apr 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Composite (or profile) of Pharmacokinetics (time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose on Day 1 and Day 1). 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 NCT01429740.

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 12 Apr 2012.