HealthyPhase 1NCT01125904
A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers
A Phase 1 study testing crizotinib in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.
- Subjects must be trained sensory panelists.
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.
Who cannot join
- A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.
- A history of hypersensitivity to any inactive ingredients employed in the formulation(s).
- Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.
- Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Woburn, Massachusetts, 01801
About this study
Official title: A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid
An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.
Read the detailed description
Taste assessment of new formulation. Subjects will not ingest the drug.
- Conditions
- Healthy
- Being tested
- crizotinib
- Keywords
- Crizotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crizotinibDrug
Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.
| Study group | Role | What they receive |
|---|---|---|
| crizotinib | Experimental | Not described Receives: Drug: crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJun 2010
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125904
- Sponsor's protocol ID
- A8081018
- Status last verified
- Jul 2010
- First submitted
- 17 May 2010
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid
- ClinicalTrials.gov ID
- NCT01125904
- Acronym / sponsor ID
- A8081018
- Conditions
- Healthy
- Keywords
- Crizotinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 May 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.
An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.
Detailed description
Taste assessment of new formulation. Subjects will not ingest the drug.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| crizotinib | Experimental | Drug: crizotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.
- Subjects must be trained sensory panelists.
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.
Key exclusion criteria (5 listed)
- A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.
- A history of hypersensitivity to any inactive ingredients employed in the formulation(s).
- Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.
- Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
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 |
|---|---|---|
| crizotinibOral liquid. Taste assessment of new formulation. Subjects will not ingest the drug. | Drug | crizotinib |
Primary outcome
A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel).
Time frame: 2 months
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 23 Jul 2010.
- 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 crizotinib in people with Healthy, 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 4 inclusion and 5 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 23 Jul 2010. 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?
A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel). (time frame: 2 months). 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 23 Jul 2010.