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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD3241 300mg extended release formulation 1 |
|
| 2 | Experimental | AZD3241 300mg extended release formulation 2 |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3241 ER formulation 1 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 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. | 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. | 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] | 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. | Day 1 until 24 hours post last dose (administered on the morning of Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Wilbraham, MBBS, DCPSA | Quintiles drug research unit, 6 Newcomen Street, SE1 1YR | Principal Investigator |
| Bjorn Paulsson, MD, PHD | Astra Zeneca, Sodertalje, Sweden | Study Director |
| Bo Fransson, MD, PHD | Astra Zeneca, Sodertalje, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | London | United Kingdom |
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| Placebo | Drug | Placebo will be administered with the same intervention scheme as intervention 1 and 2 |
|
| AZD3241 Alternative titration scheme with formulation 1 or 2 | Drug | 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 |
|
|
| λz,ss: Terminal elimination rate constant at steady state. | 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. | Day 1 until 24 hours post last dose (administered on the morning of Day 8) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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