Rheumatoid ArthritisPhase 1NCT01309854
Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects
A Phase 1 study testing fostamatinib and pioglitazone 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 pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib 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, Pharmacokinetics
- What is being tested?
- fostamatinib and pioglitazone
- 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
- 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
- Males or females (of non-child bearing potential) aged 18 to 55 years (inclusive)
- Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
- Males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product
Who cannot join
- History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
- 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 or pioglitazone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily
The purpose of this study is to investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.
- Conditions
- Rheumatoid Arthritis, Healthy Volunteers, Pharmacokinetics, Pioglitazone, Drug-drug Interaction, Amount of Pioglitazone in Blood
- Being tested
- fostamatinib, pioglitazone
- Keywords
- Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, pioglitazone, drug-drug interaction
- 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, 100mg (2 X 50mg) twice daily for 8 days
pioglitazoneDrug
oral tablets, 30mg single dose per period
| Study group | Role | What they receive |
|---|---|---|
| pioglitazone | Experimental | Not described Receives: Drug: fostamatinib; Drug: pioglitazone |
| pioglitazone and fostamatinib | Experimental | Not described Receives: Drug: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Measured: Period 1: Pre-dose to 48h post dose
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Measured: Period 2: Pre-dose to 48h post dose
Secondary outcomes (3)
To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
Measured: Period 1: Pre-dose to 48h post dose
To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
Measured: Period 2: Pre-dose to 48h post dose
To examine the safety and tolerability
To examine the safety and tolerability of fostamatinib in combination with pioglitazone. Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram
Measured: From screening, Day -1 to Day 9 and follow up visit (Day 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 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 (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Layton, MD, MRCP, Study director, AstraZenecaCarlos Prendes, MD, Principal investigator, Quintiles Overland Park, Phase 1 Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309854
- Sponsor's protocol ID
- D4300C00014
- Status last verified
- Jul 2011
- First submitted
- 21 Feb 2011
- Last updated
- 7 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily
- ClinicalTrials.gov ID
- NCT01309854
- Acronym / sponsor ID
- D4300C00014
- Conditions
- Rheumatoid Arthritis, Healthy Volunteers, Pharmacokinetics, Pioglitazone, Drug-drug Interaction, Amount of Pioglitazone in Blood
- Keywords
- Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, pioglitazone, drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 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 investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib 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 |
|---|---|---|
| pioglitazone | Experimental | Drug: fostamatinib, Drug: pioglitazone |
| pioglitazone and fostamatinib | Experimental | Drug: pioglitazone |
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 (of non-child bearing potential) aged 18 to 55 years (inclusive)
- Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
- Males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product
Key exclusion criteria (5 listed)
- History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
- 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 or pioglitazone
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, 100mg (2 X 50mg) twice daily for 8 days | Drug | pioglitazone |
| pioglitazoneoral tablets, 30mg single dose per period | Drug | pioglitazone, pioglitazone and fostamatinib |
Primary outcome
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Time frame: Period 1: Pre-dose to 48h post dose
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Time frame: Period 2: Pre-dose to 48h post dose
3 secondary outcomes
To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
Time frame: Period 1: Pre-dose to 48h post dose
To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
Time frame: Period 2: Pre-dose to 48h post dose
To examine the safety and tolerability
Time frame: From screening, Day -1 to Day 9 and follow up visit (Day 16)
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 7 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.
Mark Layton, MD, MRCP study director
AstraZeneca
Carlos Prendes, MD principal investigator
Quintiles Overland Park, Phase 1 Unit
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 pioglitazone 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 7 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 pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax (time frame: Period 1: Pre-dose to 48h post dose). 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 7 Jul 2011; AzTrials last refreshed its copy on 8 Nov 2026.