Rheumatoid ArthritisPhase 1NCT01311622
Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects
A Phase 1 study testing warfarin and fostamatinib in people with Rheumatoid Arthritis and Healthy Subjects, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Healthy Subjects
- What is being tested?
- warfarin and fostamatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to May 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures (including genotyping screening sample for CYP2C9 and VKORC1).
- Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
- Subjects must be negative for occult blood (stool card) prior to administration.
- Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
- Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
- A protein C and/or protein S deficiency.
- Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects
The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.
- Conditions
- Rheumatoid Arthritis, Healthy Subjects
- Being tested
- warfarin, fostamatinib
- Keywords
- drug-drug interaction, Phase 1, healthy subjects, warfarin, Rheumatoid arthritis, RA, fostamatinib open-label, pharmacokinetics, pharmacodynamics, level of Warfarin in the blood
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
Also called Marevan
2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart
fostamatinibDrug
2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days
| Study group | Role | What they receive |
|---|---|---|
| warfarin | Experimental | Not described Receives: Drug: warfarin |
| warfarin and fostamatinib | Experimental | Not described Receives: Drug: warfarin; Drug: fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax
- Pharmacokinetics of warfarin measured by AUC
- Pharmacokinetics of warfarin measured Cmax
Measured: From pre-dose to 168 h post dose relative to each single warfarin dose
Secondary outcomes (3)
To measure International Normalised Ratio (INR) following administration of warfarin
Measured: From pre-dose to 168 h post dose relative to each single warfarin dose
To assess the steady-state pharmacokinetics of R406 (active metabolite of fostamatinib) by measuring AUCss, Cmax,ss, tmax,ss and CL/F
- Steady state Pharmacokinetics of R406 measured by AUCss
- Steady state Pharmacokinetics of R406 measured by Cmax
- Steady state Pharmacokinetics of R406 measured by ss
- Steady state Pharmacokinetics of R406 measured by tmax
- Steady state Pharmacokinetics of R406 measured by CL/F
Measured: From predose on Day 11 until 12 h post dose on Day 14 relative to fostamatinib dosing
Safety and tolerability will be measured with regard to adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG will be recorded.
To examine the safety and tolerability of fostamatinib in combination with Warfarin: Adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG
Measured: From screening, Day -1 to Day 21 and follow up visit (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Ritter, BM BCh MRCP FRCP, Principal investigator, Quintiles, Phase 1 Unit, LondonMark Layton, MD MRCP (UK), Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311622
- Sponsor's protocol ID
- D4300C00013
- Status last verified
- Jan 2013
- First submitted
- 21 Feb 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01311622
- Acronym / sponsor ID
- D4300C00013
- Conditions
- Rheumatoid Arthritis, Healthy Subjects
- Keywords
- drug-drug interaction, Phase 1, healthy subjects, warfarin, Rheumatoid arthritis, RA, fostamatinib open-label, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Mar 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.
The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warfarin | Experimental | Drug: warfarin |
| warfarin and fostamatinib | Experimental | Drug: warfarin, Drug: fostamatinib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures (including genotyping screening sample for CYP2C9 and VKORC1).
- Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
- Subjects must be negative for occult blood (stool card) prior to administration.
- Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
- Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
- A protein C and/or protein S deficiency.
- Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).
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 |
|---|---|---|
| warfarinAlso: Marevan2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart | Drug | warfarin, warfarin and fostamatinib |
| fostamatinib2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days | Drug | warfarin and fostamatinib |
Primary outcome
To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax
Time frame: From pre-dose to 168 h post dose relative to each single warfarin dose
* Pharmacokinetics of warfarin measured by AUC * Pharmacokinetics of warfarin measured Cmax
3 secondary outcomes
To measure International Normalised Ratio (INR) following administration of warfarin
Time frame: From pre-dose to 168 h post dose relative to each single warfarin dose
To assess the steady-state pharmacokinetics of R406 (active metabolite of fostamatinib) by measuring AUCss, Cmax,ss, tmax,ss and CL/F
Time frame: From predose on Day 11 until 12 h post dose on Day 14 relative to fostamatinib dosing
Safety and tolerability will be measured with regard to adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG will be recorded.
Time frame: From screening, Day -1 to Day 21 and follow up visit (Day 28)
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 31 Jan 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.
James Ritter, BM BCh MRCP FRCP principal investigator
Quintiles, Phase 1 Unit, London
Mark Layton, MD MRCP (UK) 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 warfarin and fostamatinib in people with Rheumatoid Arthritis and Healthy Subjects, 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 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 31 Jan 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 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?
To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax (time frame: From pre-dose to 168 h post dose relative to each single warfarin dose). 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 31 Jan 2013.