HealthyPhase 1NCT00860223
Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin
A Phase 1 study testing Digoxin and Neratinib in people with Healthy, run by Puma Biotechnology, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin. 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?
- Digoxin and Neratinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2009
- 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 non-childbearing potential, age 18-50
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Nonrandomized, Crossover Study to Evaluate the Potential Effect of Multiple Doses of Neratinib on the Pharmacokinetics of a Single Dose of Digoxin When Administered Orally to Healthy Adult Subjects
The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.
- Conditions
- Healthy
- Being tested
- Digoxin, Neratinib
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigoxinDrug
NeratinibDrug
HKI-272
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Digoxin alone Receives: Drug: Digoxin |
| 2 | Experimental | Digoxin plus neratinib Receives: Drug: Digoxin; Drug: Neratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters: concentration of digoxin in blood and urine
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2009
- Study completionApr 2009
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT00860223
- Sponsor's protocol ID
- 3144A1-1119
- Status last verified
- May 2012
- First submitted
- 11 Mar 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, Nonrandomized, Crossover Study to Evaluate the Potential Effect of Multiple Doses of Neratinib on the Pharmacokinetics of a Single Dose of Digoxin When Administered Orally to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00860223
- Acronym / sponsor ID
- 3144A1-1119
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Mar 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.
The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DigoxinDigoxin alone |
| 2 | Experimental | Drug: Digoxin, Drug: NeratinibDigoxin plus neratinib |
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 non-childbearing potential, age 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 |
|---|---|---|
| Digoxin | Drug | 1, 2 |
| NeratinibHKI-272 | Drug | 2 |
Primary outcome
Pharmacokinetic parameters: concentration of digoxin in blood and urine
Time frame: 5 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
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 Digoxin and Neratinib in people with Healthy, run by Puma Biotechnology, Inc. 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 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 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?
Pharmacokinetic parameters: concentration of digoxin in blood and urine (time frame: 5 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.