HealthyPhase 1NCT00879346
A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets
A Phase 1 study testing AZD8931 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD8931
- 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 Jul 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent
- Body mass index (BMI) between 19 and 30 kg/m2
Who cannot join
- Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product
- Administration of another investigational medicinal product in the 3 months before the start of dosing in this study
- Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets in Healthy Subjects
Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.
- Conditions
- Healthy
- Being tested
- AZD8931
- Keywords
- Healthy Volunteers, ADME, Healthy male volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8931Drug
160mg oral single dose (4 x 40mg tablets)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 160mg oral dose of AZD8931 Receives: Drug: AZD8931 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose
Measured: Multiple blood PK samples taken between predose to up to 5 days post last dose
Secondary outcomes (1)
To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG
Measured: Maximus of 7 weeks (From time of consent to last visit including any follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Emeline Ramos, MD, Principal investigator, AstraZeneca, Clinical Pharamcology Unit, Alderley ParkMary Stuart, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879346
- Sponsor's protocol ID
- D0102C00011
- Status last verified
- Oct 2009
- First submitted
- 7 Apr 2009
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00879346
- Acronym / sponsor ID
- D0102C00011
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, ADME, Healthy male volunteers
- 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
- Jul 2009 (actual)
- First posted
- 10 Apr 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.
Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8931160mg oral dose of AZD8931 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of written informed consent
- Body mass index (BMI) between 19 and 30 kg/m2
Key exclusion criteria (3 listed)
- Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product
- Administration of another investigational medicinal product in the 3 months before the start of dosing in this study
- Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity
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 |
|---|---|---|
| AZD8931160mg oral single dose (4 x 40mg tablets) | Drug | 1 |
Primary outcome
To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose
Time frame: Multiple blood PK samples taken between predose to up to 5 days post last dose
1 secondary outcome
To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG
Time frame: Maximus of 7 weeks (From time of consent to last visit including any follow-up)
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 23 Oct 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.
Emeline Ramos, MD principal investigator
AstraZeneca, Clinical Pharamcology Unit, Alderley Park
Mary Stuart, MD 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 AZD8931 in people with Healthy, 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 2 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 23 Oct 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?
To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose (time frame: Multiple blood PK samples taken between predose to up to 5 days post last 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 23 Oct 2009.