HealthyPhase 1NCT00878618
Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837
A Phase 1 study testing AZD0837 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD0837
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject aged between 18 to 45 years inclusive
- Body mass index (BMI) between 19 to 30 kg/m2 inclusive
- Body weight between 50 to 100 kg inclusive
- Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.
Who cannot join
- Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
- Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
- History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
- Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Open, Randomized, Two-Way Crossover Study to Evaluate the Pharmacokinetics of the Extended-Release Test Formulation of AZD0837 Compared to the Extended-Release AZD0837 Reference Formulation After Repeated Dosing in Healthy Volunteers
The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.
- Conditions
- Healthy
- Being tested
- AZD0837
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0837Drug
Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days
AZD0837Drug
Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days
| Study group | Role | What they receive |
|---|---|---|
| HAB | Experimental | AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast Receives: Drug: AZD0837 |
| HBA | Experimental | AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast Receives: Drug: AZD0837 |
| LAB | Experimental | AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast Receives: Drug: AZD0837 |
| LBA | Experimental | AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast Receives: Drug: AZD0837 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.
Measured: Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.
Secondary outcomes (3)
To evaluate the PK of the intermediate metabolite AR-H069927XX
Measured: Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above.
Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events)
Measured: ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1.
Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4
Measured: Once predose on day 1, session 1 and once predose on day 5, session 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 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 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elisabeth Edén Eden, Principal investigator, Quintiles AB, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878618
- Sponsor's protocol ID
- D1250C00056
- Status last verified
- Jun 2009
- First submitted
- 31 Mar 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Open, Randomized, Two-Way Crossover Study to Evaluate the Pharmacokinetics of the Extended-Release Test Formulation of AZD0837 Compared to the Extended-Release AZD0837 Reference Formulation After Repeated Dosing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00878618
- Acronym / sponsor ID
- D1250C00056
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Study completion
- May 2009 (actual)
- First posted
- 9 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.
The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HAB | Experimental | Drug: AZD0837AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast |
| HBA | Experimental | Drug: AZD0837AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast |
| LAB | Experimental | Drug: AZD0837AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast |
| LBA | Experimental | Drug: AZD0837AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subject aged between 18 to 45 years inclusive
- Body mass index (BMI) between 19 to 30 kg/m2 inclusive
- Body weight between 50 to 100 kg inclusive
- Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.
Key exclusion criteria (4 listed)
- Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
- Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
- History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
- Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.
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 |
|---|---|---|
| AZD0837Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days | Drug | HAB, LAB |
| AZD0837Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days | Drug | HBA, LBA |
Primary outcome
To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.
Time frame: Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.
3 secondary outcomes
To evaluate the PK of the intermediate metabolite AR-H069927XX
Time frame: Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above.
Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events)
Time frame: ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1.
Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4
Time frame: Once predose on day 1, session 1 and once predose on day 5, session 2
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 3 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.
Elisabeth Edén 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 AZD0837 in people with Healthy, 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 4 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 3 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 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?
To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation. (time frame: Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.). 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 3 Jun 2009.