HealthyPhase 1NCT01387308
Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets
A Phase 1 study testing Fostamatinib in people with Healthy, 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
- Healthy
- What is being tested?
- Fostamatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2011
- 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
- Provision of signed and dated informed consent prior to any study specific procedures
- Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
- Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- Any clinically significant abnormalities in clinical chemistry, haematology 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, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg Fostamatinib Tablets
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.
- Conditions
- Healthy
- Being tested
- Fostamatinib
- Keywords
- Phase 1, Healthy male volunteers, pharmacokinetics, fostamatinib, Scientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_max, Laymen Terminology: Amount of R406 in blood
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, 50 mg x 3, single dose
FostamatinibDrug
Oral tablets, 100 mg, single dose
FostamatinibDrug
Oral tablets, 150 mg, single dose
FostamatinibDrug
Oral tablets, 50 mg x 2, single dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Fostamatinib 50 mg tablet x 2 (Phase 3 batch) Receives: Drug: Fostamatinib |
| B | Sham comparator | Fostamatinib 50 mg tablet x 3 (Phase 3 batch) Receives: Drug: Fostamatinib |
| C | Experimental | Fostamatinib 100 mg tablet (new formulation) Receives: Drug: Fostamatinib |
| D | Experimental | Fostamatinib 150 mg tablet (new formulation) Receives: Drug: Fostamatinib |
| E | Experimental | Fostamatinib 50 mg tablet x 2 (Phase 3 batch) Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation)
Assessments will include but is not limited to: plasma R406 AUC, Cmax
Measured: From Pre-dose until 96 hours post dose of each treatment period
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation)
Assessments will include but is not limited to: plasma R406 AUC, Cmax )
Measured: From pre-dose until 96 hours post dose of each treatment period
Secondary outcomes (2)
To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches
The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Measured: From pre-dose until 96 hours post dose of each treatment period
To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.
Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax
Measured: From pre-dose until 96 hours post dose of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
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.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387308
- Sponsor's protocol ID
- D4300C00018
- Status last verified
- Oct 2011
- First submitted
- 30 Jun 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg Fostamatinib Tablets
- ClinicalTrials.gov ID
- NCT01387308
- Acronym / sponsor ID
- D4300C00018
- Conditions
- Healthy
- Keywords
- Phase 1, Healthy male volunteers, pharmacokinetics, fostamatinib, Scientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_max, Laymen Terminology: Amount of R406 in blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Jul 2011 (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
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: FostamatinibFostamatinib 50 mg tablet x 2 (Phase 3 batch) |
| B | Sham comparator | Drug: FostamatinibFostamatinib 50 mg tablet x 3 (Phase 3 batch) |
| C | Experimental | Drug: FostamatinibFostamatinib 100 mg tablet (new formulation) |
| D | Experimental | Drug: FostamatinibFostamatinib 150 mg tablet (new formulation) |
| E | Experimental | Drug: FostamatinibFostamatinib 50 mg tablet x 2 (Phase 3 batch) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of signed and dated informed consent prior to any study specific procedures
- Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
- Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- Any clinically significant abnormalities in clinical chemistry, haematology 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 | A |
| FostamatinibOral tablets, 50 mg x 3, single dose | Drug | B |
| FostamatinibOral tablets, 100 mg, single dose | Drug | C |
| FostamatinibOral tablets, 150 mg, single dose | Drug | D |
| FostamatinibOral tablets, 50 mg x 2, single dose | Drug | E |
Primary outcome
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation)
Time frame: From Pre-dose until 96 hours post dose of each treatment period
Assessments will include but is not limited to: plasma R406 AUC, Cmax
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation)
Time frame: From pre-dose until 96 hours post dose of each treatment period
Assessments will include but is not limited to: plasma R406 AUC, Cmax )
2 secondary outcomes
To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches
Time frame: From pre-dose until 96 hours post dose of each treatment period
To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.
Time frame: From pre-dose until 96 hours post dose of each treatment period
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 28 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, 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 3 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 28 Oct 2011. 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. Some participants in this study may receive a placebo. 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?
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation) (time frame: From Pre-dose until 96 hours post dose of each treatment period). The study lists 2 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 28 Oct 2011.