Rheumatoid ArthritisPhase 1NCT01245790
A Study of Fostamatinib in Subjects With Impaired Kidney Function
A Phase 1 study testing fostamatinib in people with Rheumatoid Arthritis and Renal Impairment, run by AstraZeneca at 1 site in United States.
Trial summary
A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Renal Impairment
- 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
- Nov 2010to Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive
- Stable renal impairment with following creatinine clearance (CLCR): Stage 1 - End Stage Renal Disease (ESRD) < 15 mL/min (requiring dialysis); Stage 2 - Mild renal impairment ≥ 50 to < 80 mL/min; Moderate renal impairment ≥ 30 to <50 mL/min; and severe renal impairment 15 to < 30 mL/min
- Healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance >80 ml/min"
- Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen and hepatitis C antibody
Who cannot join
- Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
- Absolute neutrophil count less than 1600/mm3 or 1.6 x 109 L.
- Healthy subjects only: Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
- Subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib
- In the opinion of the Investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg
A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with renal impairment.
- Conditions
- Rheumatoid Arthritis, Renal Impairment
- Being tested
- fostamatinib
- Keywords
- Phase 1, healthy volunteers, volunteers with renal impairment, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, Patients
- Medical subject headings
- Arthritis, Rheumatoid, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fostamatinibDrug
Oral tablets, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Healthy subjects (Stage 1) Receives: Drug: fostamatinib |
| 2 | Experimental | Mild renal impairment (Stage 2) Receives: Drug: fostamatinib |
| 3 | Experimental | Moderate renal impairment (Stage 2) Receives: Drug: fostamatinib |
| 4 | Experimental | Severe renal impairment (Stage 2) Receives: Drug: fostamatinib |
| 5 | Experimental | End stage renal disease (Stage 1) Receives: Drug: fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetic (PK) parameters
Parameters include: AUC, Cmax
Secondary outcomes (3)
Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms
Urine PK parameters of R406 and its N-glucuronide metabolite
PK parameters including but not limited to Amount excreted (Ae) and renal clearance (CLr)
The effects of differences in protein binding by assessment of unbound R406 PK
PK parameters including, but not limited to, unbound AUC and unbound Cmaxt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Parallel groups
- 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, AstraZenecaThomas Marbury, MD, Principal investigator, Orlando Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245790
- Sponsor's protocol ID
- D4300C00009
- Status last verified
- Jun 2011
- First submitted
- 19 Nov 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin P, Oliver S, Gillen M, Marbury T, Millson D. Pharmacokinetic Properties of Fostamatinib in Patients With Renal or Hepatic Impairment: Results From 2 Phase I Clinical Studies. Clin Ther. 2015 Dec 1;37(12):2823-36. doi: 10.1016/j.clinthera.2015.09.016. Epub 2015 Oct 27.
PubMed 26519231
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg
- ClinicalTrials.gov ID
- NCT01245790
- Acronym / sponsor ID
- D4300C00009
- Conditions
- Rheumatoid Arthritis, Renal Impairment
- Keywords
- Phase 1, healthy volunteers, volunteers with renal impairment, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Nov 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.
A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with renal impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fostamatinibHealthy subjects (Stage 1) |
| 2 | Experimental | Drug: fostamatinibMild renal impairment (Stage 2) |
| 3 | Experimental | Drug: fostamatinibModerate renal impairment (Stage 2) |
| 4 | Experimental | Drug: fostamatinibSevere renal impairment (Stage 2) |
| 5 | Experimental | Drug: fostamatinibEnd stage renal disease (Stage 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive
- Stable renal impairment with following creatinine clearance (CLCR): Stage 1 - End Stage Renal Disease (ESRD) < 15 mL/min (requiring dialysis); Stage 2 - Mild renal impairment ≥ 50 to < 80 mL/min; Moderate renal impairment ≥ 30 to <50 mL/min; and severe renal impairment 15 to < 30 mL/min
- Healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance >80 ml/min"
- Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen and hepatitis C antibody
Key exclusion criteria (5 listed)
- Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
- Absolute neutrophil count less than 1600/mm3 or 1.6 x 109 L.
- Healthy subjects only: Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
- Subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib
- In the opinion of the Investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding
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, single dose | Drug | 1, 2, 3, 4, 5 |
Primary outcome
Plasma pharmacokinetic (PK) parameters
Parameters include: AUC, Cmax
3 secondary outcomes
Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms
Urine PK parameters of R406 and its N-glucuronide metabolite
The effects of differences in protein binding by assessment of unbound R406 PK
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 16 Jun 2011.
- Derived from this study: PubMed 26519231Martin P, Oliver S, Gillen M, Marbury T, Millson D. Pharmacokinetic Properties of Fostamatinib in Patients With Renal or Hepatic Impairment: Results From 2 Phase I Clinical Studies. Clin Ther. 2015 Dec 1;37(12):2823-36. doi: 10.1016/j.clinthera.2015.09.016. Epub 2015 Oct 27.
- Related InfoLink provided by the sponsor.
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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
Thomas Marbury, MD principal investigator
Orlando Clinical
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 Rheumatoid Arthritis and Renal Impairment, 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 16 Jun 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. 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?
Plasma pharmacokinetic (PK) parameters. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01245790, which also lists 1 linked publication.
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 16 Jun 2011.