HealthyPhase 1NCT01598571
Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose
A Phase 1 study testing Fostamatinib in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose. 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, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Aug 2012
- 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
- Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
- Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product
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
- 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: A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib With Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers
Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.
Read the detailed description
A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.
- Conditions
- Healthy
- Being tested
- Fostamatinib
- Keywords
- Phase 1, Healthy male volunteers, pharmacokinetics, fostamatinib, Bioavailability, R406 plasma AUC and Cmax, R406 plasma AUC0-t, t1/2λz, tmax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostamatinibDrug
Fostamatinib 50 mg tablet
FostamatinibDrug
Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose
| Study group | Role | What they receive |
|---|---|---|
| Fostamatinib 50 mg tablet | Experimental | Not described Receives: Drug: Fostamatinib |
| Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose | Experimental | Not described Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib.
Measured: Up to 96 hours post dose
Total radioactivity of [14C] R406 after an intravenous infusion of [14C]R406 in terms of AUC, AUC(0-t), Cmax, t1/2λz, MRT, CL, Vz.
AUC-Area under the plasma concentration time curve; AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax - max plasma concentration; t½ λz-Terminal half-life; MRT- Mean residence time; CL - Total body clearance; Vz - Volume of distribution during the terminal phase
Measured: Up to 96 hours post dose
Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406.
PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT
Measured: 0, 30min, 1h, 1h 30min, 1h 45min, 1h 50min, 1h 55min, 2, 2h 5min, 2h 10min, 2h 15min, 2h30min, 3, 3h 30min, 5h30min, 9h, 12h, 18h, 24h, 30h, 48h, 72h, 96h post-dose
Secondary outcomes (2)
Number of participants with Adverse Events.
Measured: Up to Day 12
Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings.
Measured: Up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Layton, MD, Study director, AstraZeneca, Alderley ParkSharan Sidhu, MB CHB, BAO, MRCS, Principal investigator, Quotient Clinical Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598571
- Sponsor's protocol ID
- D4300C00027
- Other IDs
- QBR112696
- Status last verified
- Aug 2012
- First submitted
- 5 Apr 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib With Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01598571
- Acronym / sponsor ID
- D4300C00027
- Conditions
- Healthy
- Keywords
- Phase 1, Healthy male volunteers, pharmacokinetics, fostamatinib, Bioavailability, R406 plasma AUC and Cmax, R406 plasma AUC0-t, t1/2λz
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 May 2012 (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 single fostamatinib with iv micro tracer dose.
Detailed description
A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fostamatinib 50 mg tablet | Experimental | Drug: Fostamatinib |
| Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose | Experimental | Drug: Fostamatinib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
- Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product
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
- 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 |
|---|---|---|
| FostamatinibFostamatinib 50 mg tablet | Drug | Fostamatinib 50 mg tablet |
| FostamatinibFostamatinib 100 μg [14C] R406 intravenous micro tracer dose | Drug | Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose |
Primary outcome
The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib.
Time frame: Up to 96 hours post dose
Total radioactivity of [14C] R406 after an intravenous infusion of [14C]R406 in terms of AUC, AUC(0-t), Cmax, t1/2λz, MRT, CL, Vz.
Time frame: Up to 96 hours post dose
AUC-Area under the plasma concentration time curve; AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax - max plasma concentration; t½ λz-Terminal half-life; MRT- Mean residence time; CL - Total body clearance; Vz - Volume of distribution during the terminal phase
Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406.
Time frame: 0, 30min, 1h, 1h 30min, 1h 45min, 1h 50min, 1h 55min, 2, 2h 5min, 2h 10min, 2h 15min, 2h30min, 3, 3h 30min, 5h30min, 9h, 12h, 18h, 24h, 30h, 48h, 72h, 96h post-dose
PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT
2 secondary outcomes
Number of participants with Adverse Events.
Time frame: Up to Day 12
Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings.
Time frame: Up to Day 12
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 22 Aug 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.
Mark Layton, MD study director
AstraZeneca, Alderley Park
Sharan Sidhu, MB CHB, BAO, MRCS principal investigator
Quotient Clinical Unit
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 Kingdom.
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 22 Aug 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 Kingdom. 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?
The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib. (time frame: Up to 96 hours post dose). The study lists 3 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 22 Aug 2012.