PharmacokineticsPhase 1PK CombinationNCT01682408
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
A Phase 1 study testing Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed and Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) in people with Pharmacokinetics, run by AstraZeneca at 1 site in United States.
Trial summary
Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed and Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling and analyses
- Volunteers will be males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive.
- Provision of signed, written, and dated informed consent for optional genetic research. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer.
- Male volunteers should be willing to use barrier contraception, ie, condoms from the day of first dosing until 2 weeks after dosing with the IP in Treatment Period 5.
- Females must have a negative pregnancy test at screening and on admission to the CPU (including check-in at each treatment period), must not be lactating and must be of non childbearing potential, confirmed at screening
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- 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 IP
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone in Fed and Fasted State and in Combination With Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets
Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets
Read the detailed description
An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets
- Conditions
- Pharmacokinetics
- Being tested
- Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed, Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A), Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B), Ranitidine
- Keywords
- R406,, Fostamatinib,, Phase I,, Healthy Subjects,, Pharmacokinetics,, Fed/Fasted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)Drug
1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)
Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fedDrug
3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)Drug
1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)Drug
1 x 150mg mannitol based 38% drug loaded tablet(batch variant B)
RanitidineDrug
150 mg ranitidine
| Study group | Role | What they receive |
|---|---|---|
| Part A1 | Active comparator | 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed Receives: Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference); Drug: Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed |
| Part A2 | Active comparator | 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed 150 mg ranitidine Receives: Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference); Drug: Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed; Drug: Ranitidine |
| Part B1 | Active comparator | 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) Receives: Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) |
| Part B2 | Active comparator | 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) Receives: Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) |
| Part B3 | Active comparator | 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) Receives: Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics profile of R406 in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).
Measured: Day 1 (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 (3)
Pharmacokinetic profile of R406 in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)], time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz).
Measured: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Description of the safety profile in terms of frequency of adverse events.
Measured: up to 3 - 5 days after discharge
Description of the safety profile in terms of severity of adverse events.
Measured: up to 3 - 5 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eleanor Lisbon, MD, Principal investigator, Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211Christopher D O'Brien, MD PHD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682408
- Sponsor's protocol ID
- D4300C00019
- Acronym
- PK Combination
- Status last verified
- Dec 2012
- First submitted
- 6 Sep 2012
- Last updated
- 28 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone in Fed and Fasted State and in Combination With Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets
- ClinicalTrials.gov ID
- NCT01682408
- Acronym / sponsor ID
- PK Combination / D4300C00019
- Conditions
- Pharmacokinetics
- Keywords
- R406,, Fostamatinib,, Phase I,, Healthy Subjects,, Pharmacokinetics,, Fed/Fasted
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Sep 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 to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets
Detailed description
An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A1 | Active comparator | Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Drug: Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed |
| Part A2 | Active comparator | Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Drug: Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed, Drug: Ranitidine1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed 150 mg ranitidine |
| Part B1 | Active comparator | Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) |
| Part B2 | Active comparator | Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) |
| Part B3 | Active comparator | Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling and analyses
- Volunteers will be males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive.
- Provision of signed, written, and dated informed consent for optional genetic research. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer.
- Male volunteers should be willing to use barrier contraception, ie, condoms from the day of first dosing until 2 weeks after dosing with the IP in Treatment Period 5.
- Females must have a negative pregnancy test at screening and on admission to the CPU (including check-in at each treatment period), must not be lactating and must be of non childbearing potential, confirmed at screening
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- 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 IP
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
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 |
|---|---|---|
| Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) | Drug | Part A1, Part A2, Part B3 |
| Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed | Drug | Part A1, Part A2 |
| Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) | Drug | Part B1 |
| Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)1 x 150mg mannitol based 38% drug loaded tablet(batch variant B) | Drug | Part B2 |
| Ranitidine150 mg ranitidine | Drug | Part A2 |
Primary outcome
Pharmacokinetics profile of R406 in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).
Time frame: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
3 secondary outcomes
Pharmacokinetic profile of R406 in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)], time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz).
Time frame: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Description of the safety profile in terms of frequency of adverse events.
Time frame: up to 3 - 5 days after discharge
Description of the safety profile in terms of severity of adverse events.
Time frame: up to 3 - 5 days after discharge
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 Dec 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.
Eleanor Lisbon, MD principal investigator
Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211
Christopher D O'Brien, MD PHD study director
AstraZeneca
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 - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed and Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) in people with 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 5 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 Dec 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 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 profile of R406 in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC). (time frame: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose). 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 Dec 2012.