Rheumatoid ArthritisPhase 1NCT01336218
Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
A Phase 1 study testing fostamatinib and rifampicin in people with Rheumatoid Arthritis and Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects 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 Volunteers
- What is being tested?
- fostamatinib and rifampicin
- 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 States
- Study dates
- Apr 2011to Jul 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
- Males or females aged 18 to 55 years (inclusive)
- Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
- Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential
Who cannot join
- History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
- Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
- Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- Any previous treatment with fostamatinib
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin
The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects
- Conditions
- Rheumatoid Arthritis, Healthy Volunteers
- Being tested
- fostamatinib, rifampicin
- Keywords
- Phase 1, healthy volunteers, Rheumatoid arthritis, RA, Fostamatinib, Rifampicin, drug-drug interaction, Pharmacokinetics, Amount of Rifampicin in 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.
fostamatinibDrug
oral tablets, 150mg (3 X 50mg) single dose per period
rifampicinDrug
oral tablets, 600mg (2 X 300mg) 8 doses over 8 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fostamatinib Receives: Drug: fostamatinib |
| 2 | Experimental | Rifampicin Receives: Drug: fostamatinib; Drug: rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured
Measured: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
Secondary outcomes (2)
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured
Measured: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
To examine the safety and tolerability of fostamatinib in combination with rifampicin.
Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.
Measured: From screening, Day 1 - Day 25, up to follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 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 (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336218
- Sponsor's protocol ID
- D4300C00015
- Status last verified
- Jul 2011
- First submitted
- 14 Apr 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin
- ClinicalTrials.gov ID
- NCT01336218
- Acronym / sponsor ID
- D4300C00015
- Conditions
- Rheumatoid Arthritis, Healthy Volunteers
- Keywords
- Phase 1, healthy volunteers, Rheumatoid arthritis, RA, Fostamatinib, Rifampicin, drug-drug interaction, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Apr 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 investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fostamatinibFostamatinib |
| 2 | Experimental | Drug: fostamatinib, Drug: rifampicinRifampicin |
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
- Males or females aged 18 to 55 years (inclusive)
- Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
- Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential
Key exclusion criteria (5 listed)
- History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
- Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
- Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- Any previous treatment with fostamatinib
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, 150mg (3 X 50mg) single dose per period | Drug | 1, 2 |
| rifampicinoral tablets, 600mg (2 X 300mg) 8 doses over 8 days | Drug | 2 |
Primary outcome
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured
Time frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
2 secondary outcomes
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured
Time frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
To examine the safety and tolerability of fostamatinib in combination with rifampicin.
Time frame: From screening, Day 1 - Day 25, up to follow up visit
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 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and rifampicin in people with Rheumatoid Arthritis and 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 22 Jul 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?
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured (time frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-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 22 Jul 2011.