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Also known as AZD3241 ER formulation 1, AZD3241 formulation 1
AZD3241 · 4 trials · 2 indications
Striatum Brain region: Change from baseline in microglia activation via PET By \[11C\]PBR28 binding to translocator protein
Vital signs: systolic and diastolic blood pressure and pulse including orthostatic challenge will be assessed. Change from baseline at each visit will be calculated as the visit value minus the baseline value for each vital sign: Blood Pressure, pulse rate (supine and standing), weight and oral temperature.
Assessment of general appearance, skin, head and neck, lymph nodes, thyroid, abdomen, cardiovascular, respiratory, and neurological systems, including full palpation of thyroid gland.
Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (CSSRS) The CSSRS assesses the suicidal behavior and suicidal ideation in patients. Occurrence of suicidal behavior is defined as having answered "yes" to a least 1 of the 4 suicidal behavior sub categories (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior) at any post randomization evaluation. Occurrence of suicidal ideation after randomization is defined as having answered "yes" to at least one of the suicidal ideation sub-categories (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods \[not plan\] without intent to act, active suicidal ideation with some intent to act \[without specific plan\], and active suicidal ideation with specific plan and intent) at any post randomization evaluation.
Change from baseline at each visit will be calculated as the visit value minus the baseline value for each continuous clinical chemistry, hematology and urinalysis measurements. Abnormal or out-of-range values will be flagged.
Change from baseline at each visit will be calculated as the visit value minus the baseline value for each ECG parameter: heart rate, QRS duration, PR interval, RR interval, QT and calculated QTcF interval. Abnormal or out-of-range values will be flagged.
| Arm | Type | Description |
|---|---|---|
| AZD3241 | EXPERIMENTAL | Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. |
| Placebo to match AZD3241 | PLACEBO_COMPARATOR | Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. |
| AZD3241, 300 mg | ACTIVE_COMPARATOR | AZD3241 300 mg BID |
| AZD3241, 600 mg | ACTIVE_COMPARATOR | AZD3241 600 mg BID |
| Placebo | PLACEBO_COMPARATOR | Placebo to AZD3241 |
| 1 | EXPERIMENTAL | AZD3241 300mg extended release formulation 1 |
| 2 | EXPERIMENTAL | AZD3241 300mg extended release formulation 2 |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD3241 | DRUG | Drug: AZD3241 administered for 12 weeks orally as a tablet. |
| Placebo | DRUG | Placebo to match AZD3241 administered for 12 weeks orally as a tablet. |
| AZD3241 300 mg BID | DRUG | The following dose escalation schedule will be used for 300 mg BID: 100 mg BID from Day 1 through Day 7. On Day 8, the patients will start maintenance treatment of 300 mg BID for the duration of the treatment period. |
| AZD3241 600 mg BID | DRUG | The following dose escalation schedule will be used for 600 mg BID: 100 mg BID from Day 1 through Day 7 and 300 mg BID from Day 8 through Day 14. On Day 15, the patients will start maintenance treatment of 600 mg BID for the duration of the treatment period. |
| ER tablet 25 mg AZD3241 | DRUG | 2 tablets twice daily for Day 1 |
| ER tablet 100 mg AZD3241 | DRUG | 1-6 tablets twice daily from Day 2 until Day 56±3 days |
| Placebo for AZD3241 25 mg | DRUG | 2 tablets twice daily for Day 1 |
| Placebo for AZD3241 100 mg | DRUG | 1-6 tablets twice daily from Day 2 until Day 56±3 days |
| 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 |
| 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 |
Inclusion Criteria: 1. Male or female, age 30-80 years, inclusive, at screen. 2. Meet criteria for diagnosis of probable or possible MSA according to the consensus criteria (Gilman et al. 2008 ). 3. "High-affinity binder" or "mixed-affinity binder" for TSPO, as confirmed by prospective genotyping o...
AZD3241 is an investigational small molecule developed by AstraZeneca PLC for neurological conditions. It has been studied in Phase 2 clinical trials in patients with Multiple System Atrophy (MSA) and Parkinson's disease. It is an oral therapy, including an extended-release tablet formulation, and has been evaluated in placebo-controlled, randomized, double-blind trials.
AZD3241 has been studied as a treatment for Multiple System Atrophy (MSA) and Parkinson's disease. Its Phase 2 program included a 12-week safety and tolerability trial with PET imaging in MSA patients and separate studies in Parkinson's disease patients. It remains investigational and is not an approved therapy for either condition.
AZD3241 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the clinical trial program for the drug, including the Phase 2 studies in Multiple System Atrophy and Parkinson's disease and the earlier Phase 1 formulation study in healthy volunteers.
AZD3241 is in Phase 2 development. Three Phase 2 trials have been completed, along with a Phase 1 formulation study, and no trials are currently active. The Phase 2 program enrolled patients with Multiple System Atrophy and Parkinson's disease across sites in the United States and several European countries.
Completed AZD3241 trials include NCT02388295, a Phase 2 PET safety and tolerability trial in Multiple System Atrophy; NCT01603069, a Phase 2 safety and tolerability study in Parkinson's disease; NCT01527695, a Phase 2 PET study in Parkinson's disease; and NCT01457807, a Phase 1 formulation study in healthy volunteers.