Healthy VolunteersPhase 1Fosta BENCT01645085
A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib
A Phase 1 study testing MCC-based 13% drug loaded tablets and Mannitol-based 38% drug-loaded tablet in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MCC-based 13% drug loaded tablets and Mannitol-based 38% drug-loaded tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and nonlactating, non childbearing potential females from 18 to 55 years, inclusive and with a weight of at least 50 kg and BMI between 18 and 30 kg/m2, inclusive
- Females must have a negative pregnancy test at screening and on admission to the study center of each period, must not be lactating and must be of non childbearing potential
- Non childbearing potential can be confirmed by being postmenopausal defined as amenorrhea for a least 12 months following cessation of all exogenous hormonal treatments and with FSH and LH levels in the laboratory-defined postmenopausal range
- Non childbearing potential can be confirmed by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
Who cannot join
- History of any clinically significant disease or disorder, including GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
- Known or suspected history of drug abuse, as judge by the investigator
- Any clinically significant abnormalities on 12-lead ECG as judged by the Investigator
- Current smokers, or those who have smoked, used nicotine-containing products, or used smoking cessation treatments within the previous 1 month prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers When 100 and 150mg of Fostamatinib Are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet
A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.
Read the detailed description
An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers when 100 and 150mg of Fostamatinib are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet.
Treatment sequences will be determined using two 2-2 crossover designs in sequence, 1 for treatments A and B, and 1 for treatments C and D. The order of the designs containing AB/BA and CD/DC within the overall design, as well as the order of treatments within each design, will be randomized. This gives a total of 8 possible treatment sequences as follows: ABCD, ABDC, BACD, BADC, CDAB, CDBA, DCAB, DCBA.
- Conditions
- Healthy Volunteers
- Being tested
- MCC-based 13% drug loaded tablets, Mannitol-based 38% drug-loaded tablet
- Keywords
- R406, Fostamatinib, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCC-based 13% drug loaded tabletsDrug
50mg tablets, dosed as 2 tablets (100mg total)
Mannitol-based 38% drug-loaded tabletDrug
One 100mg tablet
MCC-based 13% drug loaded tabletsDrug
3 tablets (150mg total)
Mannitol-based 38% drug-loaded tabletDrug
One 150 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 100mg MCC-based 13% drug-loaded tablets Receives: Drug: MCC-based 13% drug loaded tablets |
| Treatment B | Experimental | 100mg mannitol-based 38% drug-loaded tablets Receives: Drug: Mannitol-based 38% drug-loaded tablet |
| Treatment C | Experimental | 150mg MCC-based 13% drug-loaded tablets Receives: Drug: MCC-based 13% drug loaded tablets |
| Treatment D | Experimental | 150mg mannitol-based 38% drug-loaded tablets Receives: Drug: Mannitol-based 38% drug-loaded tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of R406 when fostamatinib is administered as two 50mg MCC-based 13% drug-loaded tablets versus one 100mg mannitol-based 38% drug-loaded tablet
Measured: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Bioequivalence of R406 when fostamatinib is administered as three 50mg MCC-based 13% drug-loaded tablets versus one 150mg mannitol-based 38% drug-loaded tablet
Measured: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Secondary outcomes (4)
AUC for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets
Measured: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Cmax for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets
Measured: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdoses
Frequency of adverse events
Measured: Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days
Severity of adverse events
Measured: Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris O'Brien, MEDICAL SCIENCE DIRECTOR, Study director, AstraZenecaDavid Mathews, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645085
- Sponsor's protocol ID
- D4300C00020
- Acronym
- Fosta BE
- Status last verified
- Mar 2013
- First submitted
- 13 Jul 2012
- Last updated
- 19 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers When 100 and 150mg of Fostamatinib Are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet
- ClinicalTrials.gov ID
- NCT01645085
- Acronym / sponsor ID
- Fosta BE / D4300C00020
- Conditions
- Healthy Volunteers
- Keywords
- R406, Fostamatinib, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jul 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.
A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.
Detailed description
An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers when 100 and 150mg of Fostamatinib are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet.
Treatment sequences will be determined using two 2-2 crossover designs in sequence, 1 for treatments A and B, and 1 for treatments C and D. The order of the designs containing AB/BA and CD/DC within the overall design, as well as the order of treatments within each design, will be randomized. This gives a total of 8 possible treatment sequences as follows: ABCD, ABDC, BACD, BADC, CDAB, CDBA, DCAB, DCBA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: MCC-based 13% drug loaded tablets100mg MCC-based 13% drug-loaded tablets |
| Treatment B | Experimental | Drug: Mannitol-based 38% drug-loaded tablet100mg mannitol-based 38% drug-loaded tablets |
| Treatment C | Experimental | Drug: MCC-based 13% drug loaded tablets150mg MCC-based 13% drug-loaded tablets |
| Treatment D | Experimental | Drug: Mannitol-based 38% drug-loaded tablet150mg mannitol-based 38% drug-loaded tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and nonlactating, non childbearing potential females from 18 to 55 years, inclusive and with a weight of at least 50 kg and BMI between 18 and 30 kg/m2, inclusive
- Females must have a negative pregnancy test at screening and on admission to the study center of each period, must not be lactating and must be of non childbearing potential
- Non childbearing potential can be confirmed by being postmenopausal defined as amenorrhea for a least 12 months following cessation of all exogenous hormonal treatments and with FSH and LH levels in the laboratory-defined postmenopausal range
- Non childbearing potential can be confirmed by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder, including GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
- Known or suspected history of drug abuse, as judge by the investigator
- Any clinically significant abnormalities on 12-lead ECG as judged by the Investigator
- Current smokers, or those who have smoked, used nicotine-containing products, or used smoking cessation treatments within the previous 1 month prior to enrollment
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 |
|---|---|---|
| MCC-based 13% drug loaded tablets50mg tablets, dosed as 2 tablets (100mg total) | Drug | Treatment A |
| Mannitol-based 38% drug-loaded tabletOne 100mg tablet | Drug | Treatment B |
| MCC-based 13% drug loaded tablets3 tablets (150mg total) | Drug | Treatment C |
| Mannitol-based 38% drug-loaded tabletOne 150 mg tablet | Drug | Treatment D |
Primary outcome
Bioequivalence of R406 when fostamatinib is administered as two 50mg MCC-based 13% drug-loaded tablets versus one 100mg mannitol-based 38% drug-loaded tablet
Time frame: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Bioequivalence of R406 when fostamatinib is administered as three 50mg MCC-based 13% drug-loaded tablets versus one 150mg mannitol-based 38% drug-loaded tablet
Time frame: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
4 secondary outcomes
AUC for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets
Time frame: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Cmax for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets
Time frame: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdoses
Frequency of adverse events
Time frame: Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days
Severity of adverse events
Time frame: Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 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 19 Mar 2013.
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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.
Chris O'Brien, MEDICAL SCIENCE DIRECTOR study director
AstraZeneca
David Mathews, 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 MCC-based 13% drug loaded tablets and Mannitol-based 38% drug-loaded tablet in people with Healthy Volunteers, 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 4 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 19 Mar 2013. 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?
Bioequivalence of R406 when fostamatinib is administered as two 50mg MCC-based 13% drug-loaded tablets versus one 100mg mannitol-based 38% drug-loaded tablet (time frame: Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose). 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 19 Mar 2013.