HealthyPhase 1NCT01080365
Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions
A Phase 1 study testing SKI-606 (Bosutinib) in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
Study comparing 2 formulations of bosutinib in healthy subjects. 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?
- SKI-606 (Bosutinib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women of nonchildbearing potential age 18 to 50 years
Who cannot join
- Any clinically significant medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Tacoma, Washington, 98418
About this study
Official title: A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects
Study comparing 2 formulations of bosutinib in healthy subjects.
- Conditions
- Healthy
- Being tested
- SKI-606 (Bosutinib)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKI-606 (Bosutinib)Drug
Also called Bosutinib
500 mg commercial formulation film coated tablet, administered once daily
SKI-606 (Bosutinib)Drug
Also called Bosutinib
500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Commercial Tablet Receives: Drug: SKI-606 (Bosutinib) |
| 2 | Experimental | Clinical Tablet Receives: Drug: SKI-606 (Bosutinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 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.
- 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080365
- Sponsor's protocol ID
- 3160A4-1120
- Other IDs
- B1871016
- Status last verified
- Sep 2010
- First submitted
- 2 Mar 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01080365
- Acronym / sponsor ID
- 3160A4-1120
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Mar 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.
Study comparing 2 formulations of bosutinib in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SKI-606 (Bosutinib)Commercial Tablet |
| 2 | Experimental | Drug: SKI-606 (Bosutinib)Clinical Tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men or women of nonchildbearing potential age 18 to 50 years
Key exclusion criteria (1 listed)
- Any clinically significant medical condition
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 |
|---|---|---|
| SKI-606 (Bosutinib)Also: Bosutinib500 mg commercial formulation film coated tablet, administered once daily | Drug | 1 |
| SKI-606 (Bosutinib)Also: Bosutinib500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily | Drug | 2 |
Primary outcome
Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2
Time frame: 2 weeks
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 6 Sep 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 SKI-606 (Bosutinib) in people with Healthy, run by Wyeth is now a wholly owned subsidiary of 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 6 Sep 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?
Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2 (time frame: 2 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 6 Sep 2010; AzTrials last refreshed its copy on 30 Oct 2026.