Parkinson's DiseasePhase 1NCT01457807
To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers
A Phase 1 study testing AZD3241 ER formulation 1 and AZD3241 Alternative titration scheme with formulation 1 or 2 in people with Parkinson's Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new, different extended release formulations of tablets of AZD3241 (300 mg), in relation to the 100 mg extended release tablet used in a previous study and potential food interaction. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- AZD3241 ER formulation 1 and AZD3241 Alternative titration scheme with formulation 1 or 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Dec 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture
- Female volunteers must have a negative pregnancy test at Screening and on admission to the CPU, must not be lactating and must be of non childbearing potential, confirmed at Screening
- Male volunteers must be willing to use barrier contraception ie, condoms, from the first day of dose administration until 3 months after the last dose of the IP
- Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Who cannot join
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3241
- Orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg decrease in diastolic BP as measured at enrolment and/or randomisation
- History of intolerance or hypersensitivity to mannitol
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF)>450 ms or shortened QTcF<340 ms or a family history of long QT syndrome
- Abnormal vital signs, after 10 minutes of rest in supine position, defined as any of the following:Systolic BP>140 mmHg., Diastolic BP>90 mmHg., Heart rate<40 or >85 beats per minute.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female Volunteers
To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new, different extended release formulations of tablets of AZD3241 (300 mg), in relation to the 100 mg extended release tablet used in a previous study and potential food interaction. The safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In addition to these a number of exploratory objectives will be investigated with blood sampling.
Read the detailed description
A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy Male and Female Volunteers
- Conditions
- Parkinson's Disease
- Being tested
- AZD3241 ER formulation 1, Placebo, AZD3241 Alternative titration scheme with formulation 1 or 2
- Keywords
- Phase 1, Parkinson's disease, pharmacodynamic, biomarkers, pharmacokinetics, extended release formulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3241 ER formulation 1Drug
Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast
PlaceboDrug
Placebo will be administered with the same intervention scheme as intervention 1 and 2
AZD3241 Alternative titration scheme with formulation 1 or 2Drug
Also called This titration scheme will only be used if ER formulations 1 or 2 are not well tolerated
50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD3241 300mg extended release formulation 1 Receives: Drug: AZD3241 ER formulation 1; Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 |
| 2 | Experimental | AZD3241 300mg extended release formulation 2 Receives: Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-12),ss: Area under the plasma concentration-time curve from time zero to the end of the 12-hour dosing interval at steady state.
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
AUC(0-12),ss/DN: Area under the plasma concentration-time curve from time zero to the end of the 12-hour dosing interval at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,max: Observed maximum plasma concentration at steady state.Css,max/DN Observed maximum plasma concentration at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241.
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,min: Observed minimum plasma concentration at steady state.Css,min/DN Observed minimum plasma concentration at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241.
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,av: Average plasma concentration during the 12-hour dosing interval at steady state calculated as follows: AUC(0-12),ss/12 h.
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Description of fluctuation at steady-state [(Css,max-Css,min)/Css,av]
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
AUC(0-t),ss: Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
λz,ss: Terminal elimination rate constant at steady state.
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
t½λz,ss: Half-life of terminal elimination phase at steady state.
Measured: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Secondary outcomes (1)
Description of the safety and tolerability profile in terms of Adverse Events of 8 days of administration of AZD3241, up to steady state (300 mg twice daily), of 2 new, different extended release tablets of AZD3241 (300 mg), including initial titration.
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Wilbraham, MBBS, DCPSA, Principal investigator, Quintiles drug research unit, 6 Newcomen Street, SE1 1YRBjorn Paulsson, MD, PHD, Study director, Astra Zeneca, Sodertalje, SwedenBo Fransson, MD, PHD, Study chair, Astra Zeneca, Sodertalje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457807
- Sponsor's protocol ID
- D0490C00003
- Status last verified
- Aug 2012
- First submitted
- 10 Oct 2011
- Last updated
- 17 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT01457807
- Acronym / sponsor ID
- D0490C00003
- Conditions
- Parkinson's Disease
- Keywords
- Phase 1, Parkinson's disease, pharmacodynamic, biomarkers, pharmacokinetics, extended release formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Oct 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.
To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new, different extended release formulations of tablets of AZD3241 (300 mg), in relation to the 100 mg extended release tablet used in a previous study and potential food interaction. The safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In addition to these a number of exploratory objectives will be investigated with blood sampling.
Detailed description
A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy Male and Female Volunteers
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3241 ER formulation 1, Drug: AZD3241 Alternative titration scheme with formulation 1 or 2AZD3241 300mg extended release formulation 1 |
| 2 | Experimental | Drug: AZD3241 Alternative titration scheme with formulation 1 or 2AZD3241 300mg extended release formulation 2 |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture
- Female volunteers must have a negative pregnancy test at Screening and on admission to the CPU, must not be lactating and must be of non childbearing potential, confirmed at Screening
- Male volunteers must be willing to use barrier contraception ie, condoms, from the first day of dose administration until 3 months after the last dose of the IP
- Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Key exclusion criteria (5 listed)
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3241
- Orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg decrease in diastolic BP as measured at enrolment and/or randomisation
- History of intolerance or hypersensitivity to mannitol
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF)>450 ms or shortened QTcF<340 ms or a family history of long QT syndrome
- Abnormal vital signs, after 10 minutes of rest in supine position, defined as any of the following:Systolic BP>140 mmHg., Diastolic BP>90 mmHg., Heart rate<40 or >85 beats per minute.
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 |
|---|---|---|
| AZD3241 ER formulation 1Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast | Drug | 1 |
| PlaceboPlacebo will be administered with the same intervention scheme as intervention 1 and 2 | Drug | 3 |
| AZD3241 Alternative titration scheme with formulation 1 or 2Also: This titration scheme will only be used if ER formulations 1 or 2 are not well tolerated50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8 | Drug | 1, 2 |
Primary outcome
AUC(0-12),ss: Area under the plasma concentration-time curve from time zero to the end of the 12-hour dosing interval at steady state.
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
AUC(0-12),ss/DN: Area under the plasma concentration-time curve from time zero to the end of the 12-hour dosing interval at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,max: Observed maximum plasma concentration at steady state.Css,max/DN Observed maximum plasma concentration at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241.
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,min: Observed minimum plasma concentration at steady state.Css,min/DN Observed minimum plasma concentration at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241.
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,av: Average plasma concentration during the 12-hour dosing interval at steady state calculated as follows: AUC(0-12),ss/12 h.
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Description of fluctuation at steady-state [(Css,max-Css,min)/Css,av]
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
AUC(0-t),ss: Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
λz,ss: Terminal elimination rate constant at steady state.
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
t½λz,ss: Half-life of terminal elimination phase at steady state.
Time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)
1 secondary outcome
Description of the safety and tolerability profile in terms of Adverse Events of 8 days of administration of AZD3241, up to steady state (300 mg twice daily), of 2 new, different extended release tablets of AZD3241 (300 mg), including initial titration.
Time frame: Day 1 to Day 8
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 17 Aug 2012.
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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.
Darren Wilbraham, MBBS, DCPSA principal investigator
Quintiles drug research unit, 6 Newcomen Street, SE1 1YR
Bjorn Paulsson, MD, PHD study director
Astra Zeneca, Sodertalje, Sweden
Bo Fransson, MD, PHD study chair
Astra Zeneca, Sodertalje, 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 AZD3241 ER formulation 1 and AZD3241 Alternative titration scheme with formulation 1 or 2 in people with Parkinson's Disease, 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 5 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 17 Aug 2012. 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. Some participants in this study may receive a placebo. 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?
AUC(0-12),ss: Area under the plasma concentration-time curve from time zero to the end of the 12-hour dosing interval at steady state. (time frame: Day 1 until 24 hours post last dose (administered on the morning of Day 8)). The study lists 9 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 17 Aug 2012.