BioavailabilityPhase 1NCT01208155
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
A Phase 1 study testing Fostamatinib in people with Bioavailability and Pharmacokinetics, run by AstraZeneca at 1 site in United States.
Trial summary
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability, Pharmacokinetics
- What is being tested?
- Fostamatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight of at least 50 kg and body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
- Volunteers must be willing to use barrier contraception ie, condoms, from the Day 1 of Treatment Period 1 until 2 weeks after the final dosing of the investigational product (IP)
Who cannot join
- History of any clinically significant disease or disorder
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
- Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets
- Conditions
- Bioavailability, Pharmacokinetics
- Being tested
- Fostamatinib
- Keywords
- Phase 1, Healthy, pharmacokinetics, Fostamatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostamatinibDrug
Oral tablets, 50 mg x 2, single dose
FostamatinibDrug
Oral tablets, 100 mg Batch 1, single dose
FostamatinibDrug
Oral tablets, 100 mg Batch 2, single dose
FostamatinibDrug
Oral tablets, 100 mg Batch 3, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fostamatinib 50 mg tablet x 2 Receives: Drug: Fostamatinib |
| 2 | Experimental | Fostamatinib 100 mg tablet (batch 1) Receives: Drug: Fostamatinib |
| 3 | Experimental | Fostamatinib 100 mg tablet (batch 2) Receives: Drug: Fostamatinib |
| 4 | Experimental | Fostamatinib 100 mg tablet (batch 4) Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 1 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 2 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 3 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 1 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 2 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 3 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Measured: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
Secondary outcomes (1)
To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Measured: Screening, throughout the 4 treatment periods, and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Layton, MD, Study director, AstraZenecaCarlos Prendes, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208155
- Sponsor's protocol ID
- D4300C00016
- Status last verified
- Dec 2010
- First submitted
- 22 Sep 2010
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets
- ClinicalTrials.gov ID
- NCT01208155
- Acronym / sponsor ID
- D4300C00016
- Conditions
- Bioavailability, Pharmacokinetics
- Keywords
- Phase 1, Healthy, pharmacokinetics, Fostamatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Sep 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 in healthy males to assess bioavailability of 4 different fostamatinib tablets
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FostamatinibFostamatinib 50 mg tablet x 2 |
| 2 | Experimental | Drug: FostamatinibFostamatinib 100 mg tablet (batch 1) |
| 3 | Experimental | Drug: FostamatinibFostamatinib 100 mg tablet (batch 2) |
| 4 | Experimental | Drug: FostamatinibFostamatinib 100 mg tablet (batch 4) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weight of at least 50 kg and body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
- Volunteers must be willing to use barrier contraception ie, condoms, from the Day 1 of Treatment Period 1 until 2 weeks after the final dosing of the investigational product (IP)
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
- Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator
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 |
|---|---|---|
| FostamatinibOral tablets, 50 mg x 2, single dose | Drug | 1 |
| FostamatinibOral tablets, 100 mg Batch 1, single dose | Drug | 2 |
| FostamatinibOral tablets, 100 mg Batch 2, single dose | Drug | 3 |
| FostamatinibOral tablets, 100 mg Batch 3, single dose | Drug | 4 |
Primary outcome
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 2 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 3 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 2 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 3 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
1 secondary outcome
To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Time frame: Screening, throughout the 4 treatment periods, and follow-up
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 8 Dec 2010.
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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.
Mark Layton, MD study director
AstraZeneca
Carlos Prendes, MD principal investigator
Quintiles, Inc.
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 Fostamatinib in people with Bioavailability and Pharmacokinetics, run by AstraZeneca 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 2 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 8 Dec 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?
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) (time frame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period). The study lists 8 primary outcomes in all. 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 8 Dec 2010.