SchizophreniaPhase 1NCT00150215
A First In Human Study Of PF-00184562 In Healthy Volunteers
A Phase 1 study testing PF-00184562 and Olanzapine in people with Schizophrenia, run by Pfizer at 1 site in United States.
Trial summary
The purposes of this study are: To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine. 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-00184562 and Olanzapine
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Oct 2005
- 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 or female subjects of non-childbearing potential
Who cannot join
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
The purposes of this study are:
- To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and
- To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
- Conditions
- Schizophrenia
- Being tested
- PF-00184562, Olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00184562Drug
OlanzapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)
Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).
Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
All measurements to be assessed over single doses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2005
- Study completionOct 2005
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150215
- Sponsor's protocol ID
- A6241001
- Status last verified
- Apr 2006
- First submitted
- 6 Sep 2005
- Last updated
- 25 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00150215
- Acronym / sponsor ID
- A6241001
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Jul 2005
- Study completion
- Oct 2005
- First posted
- 8 Sep 2005 (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 purposes of this study are:
- To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and
- To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female subjects of non-childbearing potential
Key exclusion criteria (1 listed)
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
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-00184562 | Drug | – |
| Olanzapine | Drug | – |
Primary outcome
Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)
Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).
Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
All measurements to be assessed over single doses.
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 25 Jul 2006.
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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 PF-00184562 and Olanzapine 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 25 Jul 2006. 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. 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?
Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2006.