HealthyPhase 1NCT00918398
AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
A Phase 1 study testing AZD1981 in people with Healthy and Postmenopausal, run by AstraZeneca at 1 site in Sweden.
Trial summary
The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Postmenopausal, Surgically Sterile Women
- What is being tested?
- AZD1981
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Men or post-menopausal or surgically sterile women, aged 18 to 55 years
- Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)
Who cannot join
- Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
- Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration
The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance
- Conditions
- Healthy, Postmenopausal, Surgically Sterile Women
- Being tested
- AZD1981
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1981Drug
100 mg iv infusion, single dose, 4 hours infusion
AZD1981Drug
514 mg oral solution, single dose
AZD1981Drug
500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose
AZD1981Drug
500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD1981, 100 mg iv infusion Receives: Drug: AZD1981 |
| 2 | Experimental | AZD1981, 514 mg oral solution Receives: Drug: AZD1981 |
| 3 | Experimental | AZD1981, 500 mg oral tablet A Receives: Drug: AZD1981 |
| 4 | Experimental | AZD1981, 500 mg oral tablet B Receives: Drug: AZD1981 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK samples for AZD1981 from both blood and urine
Measured: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.
Secondary outcomes (1)
Safety variables (adverse events and laboratory safety lab)
Measured: Adverese events registered during study and vital signs and ECG at visit 1,2 ,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva Pettersson, Study director, AstraZeneca R&D, Lund, SwedenElisabeth Eden, Principal investigator, Quintiles AB, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918398
- Sponsor's protocol ID
- D9831C00003
- Other IDs
- EudraCT No. 2009-010964-40
- Status last verified
- Jul 2009
- First submitted
- 10 Jun 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration
- ClinicalTrials.gov ID
- NCT00918398
- Acronym / sponsor ID
- D9831C00003
- Conditions
- Healthy, Postmenopausal, Surgically Sterile Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Jun 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 primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1981AZD1981, 100 mg iv infusion |
| 2 | Experimental | Drug: AZD1981AZD1981, 514 mg oral solution |
| 3 | Experimental | Drug: AZD1981AZD1981, 500 mg oral tablet A |
| 4 | Experimental | Drug: AZD1981AZD1981, 500 mg oral tablet B |
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
- Men or post-menopausal or surgically sterile women, aged 18 to 55 years
- Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)
Key exclusion criteria (2 listed)
- Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
- Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
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 |
|---|---|---|
| AZD1981100 mg iv infusion, single dose, 4 hours infusion | Drug | 1 |
| AZD1981514 mg oral solution, single dose | Drug | 2 |
| AZD1981500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose | Drug | 3 |
| AZD1981500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose | Drug | 4 |
Primary outcome
PK samples for AZD1981 from both blood and urine
Time frame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.
1 secondary outcome
Safety variables (adverse events and laboratory safety lab)
Time frame: Adverese events registered during study and vital signs and ECG at visit 1,2 ,6
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 Jul 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.
Eva Pettersson study director
AstraZeneca R&D, Lund, Sweden
Elisabeth Eden principal investigator
Quintiles AB, Uppsala, Sweden
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 AZD1981 in people with Healthy and Postmenopausal, run by AstraZeneca at 1 site in Sweden.
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 2 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 Jul 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 Sweden. 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?
PK samples for AZD1981 from both blood and urine (time frame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after 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 30 Jul 2009.