Rheumatoid ArthritisPhase 1NCT00871767
AZD5672 Bioavailability Study in Healthy Male and Female Subjects
A Phase 1 study testing AZD5672 in people with Rheumatoid Arthritis, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies 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
- What is being tested?
- AZD5672
- 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 Kingdom
- Study dates
- Mar 2009to May 2009
- 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
- BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Non smokers or past smokers who have stopped smoking within the last 6 months.
Who cannot join
- History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
- Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
- Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects
The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies
- Conditions
- Rheumatoid Arthritis
- Being tested
- AZD5672
- Keywords
- AZD5672, relative bioavailability, rheumatoid arthritis (RA)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5672Drug
40 mg tablet (Test formulation)
AZD5672Drug
40 mg tablet (Reference formulation)
AZD5672Drug
100 mg tablet (Test formulation)
AZD5672Drug
100 mg (2 x 50 mg tablet (Reference Formulation)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 40 or 100mg AZD5672, Reference formulation Receives: Drug: AZD5672 |
| 2 | Experimental | 40 or 100mg AZD5672, Test formulation Receives: Drug: AZD5672 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Measured: Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
Secondary outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
Measured: AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Study completionMay 2009
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Layton, Study chair, AstraZeneca R&D, Alderley Park, UKSimon Constable, Principal investigator, ICON Development Solutions, Manchester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871767
- Sponsor's protocol ID
- D1710C00019
- Other IDs
- EudraCt No. 2009-009423-10
- Status last verified
- Jun 2009
- First submitted
- 26 Mar 2009
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00871767
- Acronym / sponsor ID
- D1710C00019
- Conditions
- Rheumatoid Arthritis
- Keywords
- AZD5672, relative bioavailability, rheumatoid arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Study completion
- May 2009 (actual)
- First posted
- 30 Mar 2009 (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 aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD567240 or 100mg AZD5672, Reference formulation |
| 2 | Experimental | Drug: AZD567240 or 100mg AZD5672, Test formulation |
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
- BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Non smokers or past smokers who have stopped smoking within the last 6 months.
Key exclusion criteria (3 listed)
- History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
- Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
- Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
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 |
|---|---|---|
| AZD567240 mg tablet (Test formulation) | Drug | 2 |
| AZD567240 mg tablet (Reference formulation) | Drug | 1 |
| AZD5672100 mg tablet (Test formulation) | Drug | 2 |
| AZD5672100 mg (2 x 50 mg tablet (Reference Formulation) | Drug | 1 |
Primary outcome
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Time frame: Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
1 secondary outcome
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time frame: AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period
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 30 Jun 2009.
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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 study chair
AstraZeneca R&D, Alderley Park, UK
Simon Constable principal investigator
ICON Development Solutions, Manchester, UK
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 AZD5672 in people with Rheumatoid Arthritis, 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 3 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 30 Jun 2009. 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?
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss (time frame: Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28). 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 30 Jun 2009.