HealthyPhase 1NCT00932464
Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib
A Phase 1 study testing Neratinib in people with Healthy, run by Puma Biotechnology, Inc..
Trial summary
This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neratinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Aug 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women of nonchildbearing potential, age 18 to 50 years.
Who cannot join
- Any previous or current clinically significant medical condition or disease.
About this study
Official title: An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of The 240 mg Formulation Of Neratinib In Healthy Subjects
This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.
- Conditions
- Healthy
- Being tested
- Neratinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeratinibDrug
Also called HKI-272
240-mg oral tablet; single dose under fasted conditions
NeratinibDrug
Also called HKI-272
240-mg oral tablet; single dose with high-fat breakfast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Neratinib Fasted Receives: Drug: Neratinib |
| 2 | Experimental | Neratinib Fed Receives: Drug: Neratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startAug 2012
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Study withdrawn as it no longer is deemed necessary per project status.
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.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puma Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Puma, Study director, Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932464
- Sponsor's protocol ID
- 3144A2-1112
- Other IDs
- B1891007
- Status last verified
- May 2012
- First submitted
- 1 Jul 2009
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of The 240 mg Formulation Of Neratinib In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00932464
- Acronym / sponsor ID
- 3144A2-1112
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn as it no longer is deemed necessary per project status.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 3 Jul 2009 (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.
This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NeratinibNeratinib Fasted |
| 2 | Experimental | Drug: NeratinibNeratinib Fed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women of nonchildbearing potential, age 18 to 50 years.
Key exclusion criteria (1 listed)
- Any previous or current clinically significant medical condition or disease.
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 |
|---|---|---|
| NeratinibAlso: HKI-272240-mg oral tablet; single dose under fasted conditions | Drug | 1 |
| NeratinibAlso: HKI-272240-mg oral tablet; single dose with high-fat breakfast | Drug | 2 |
Primary outcome
Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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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.
Puma study director
Biotechnology
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neratinib in people with Healthy, run by Puma Biotechnology, Inc..
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: withdrawn, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2 (time frame: 6 weeks). 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 14 May 2012.