Healthy SubjectsPhase 1NCT00757809
Study Evaluating The Tolerability Of Multiple Doses Of HKI-272
A Phase 1 study testing neratinib in people with Healthy Subjects, run by Puma Biotechnology, Inc. at 2 sites in United States.
Trial summary
Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- neratinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Oct 2008
- 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 male and female (non-child bearing potential) subjects
- Ages 18-50.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Austin, Texas, 78752
Study site
Tacoma, Washington, 98418
About this study
Official title: A Blinded, Randomized, Multiple-Dose, Parallel Group Study to Characterize the Occurrence of Mild to Moderate Diarrhea After Administration of Neratinib Either 240-mg Once Daily or 120-mg Twice Daily for 14 Days to Healthy Subjects
Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.
- Conditions
- Healthy Subjects
- Being tested
- neratinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neratinibDrug
HKI-272
| Study group | Role | What they receive |
|---|---|---|
| QD | Experimental | Once daily Receives: Drug: neratinib |
| BID | Experimental | Twice daily Receives: Drug: neratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of diarrhea
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 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
- NCT00757809
- Sponsor's protocol ID
- 3144A1-1116
- Status last verified
- May 2012
- First submitted
- 19 Sep 2008
- 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
- A Blinded, Randomized, Multiple-Dose, Parallel Group Study to Characterize the Occurrence of Mild to Moderate Diarrhea After Administration of Neratinib Either 240-mg Once Daily or 120-mg Twice Daily for 14 Days to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00757809
- Acronym / sponsor ID
- 3144A1-1116
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Sep 2008 (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.
Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QD | Experimental | Drug: neratinibOnce daily |
| BID | Experimental | Drug: neratinibTwice daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female (non-child bearing potential) subjects
- Ages 18-50.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| neratinibHKI-272 | Drug | BID, QD |
Primary outcome
Occurence of diarrhea
Time frame: 14 days
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 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing neratinib in people with Healthy Subjects, run by Puma Biotechnology, Inc. at 2 sites 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 2 inclusion and 0 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 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Occurence of diarrhea (time frame: 14 days). 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.