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Three-part study investigating the safety and tolerability of AZD2423 multiple doses in 98 healthy volunteers: Part 1 80 young and elderly subjects in a parallel, double blind, randomised study. Part 2 - 6 subjects in an open, non-randomised study. Part 3 - 12 subjects in a three-way cross over, open label, partially randomised study.
Part 1 has 2 Arms, AZD2423 or Placebo, Multiple dosing during 10-14 days . Part 2 has 1 Arm AZD2423 Multiple dosing and Part 3 has 3 Arms AZD2423 single dosing or AZD2423 single dosing with food or AZD2423 single dosing, Fasting Condition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 AZD2423 or Placebo | Experimental | AZD2423 or Placebo Oral Solution, multiple dosing during 10-14 days |
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| Part 2 - AZD2423 | Experimental | AZD2423 Oral solution, multiple dosing |
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| Part 3 - AZD2423 | Experimental | AZD2423 Oral solution single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1 - AZD2423 or Placebo | Drug | AZD2423 Oral Solution, multiple dosing during 10-14 days or Placebo Oral Solution, multiple dosing during 10-14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Investigate the safety and tolerability of AZD2423 in young and elderly subjects following multiple ascending doses at steady state and, if possible, estimate the maximum tolerated dose if within the predefined exposure limits (Part 1 and 2 only). | Part 1:Safety samples taken frequently throughout the study at screening, d-1 and from days 2-16 and at the follow up visit. Part 2: Safety samples taken frequently throughout the study at screening, d-1 and from days 1-9 and at follow up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize multiple dose PK of AZD2423 and assess time required to reach steady state, degree of accumulation and time dependency of PK (Part 1 and Part 2 only). Characterize single and multiple dose PK of AZD2423 in elderly subjects (Part 1 only) | Part 1: PK will be taken days 1-14 inclusive and at follow-up, with a full PK day on Day 1 and 14. Part 2: PK samples taken on days 1-9 and at follow up visit. Day 1 and 8 is a full PK day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Muna Albayaty | PAREXEL Early Phase Clinical Uniit, London | Principal Investigator |
| Richard Malamut | AstraZeneca R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | United Kingdom |
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| Part 2 - AZD2423 | Drug | AZD2423 Oral solution, multiple dosing |
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| Part 3 - AZD2423 | Drug | AZD2423 Oral solution, single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition. |
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| To investigate concentration of AZD2423 in cerebrospinal fluid (CSF) (Part 2 only). | Part 2: CSF Samples will be taken on day 8 at 4 and 24 hours post dose. |
| Investigate the PK of tablet formulation compared to oral solution, effect of food compared to fasting, and investigate the safety and tolerability of oral solution and tablet formulation of AZD2423 in young subjects after admin. of single dose (Part 3) | Safety samples taken frequently throughout the study at screening, d-1 and from days 2+3 7-10, 14, 16+17 and at the follow up visit. PK samples will be taken on days 1-4, 8-11, 15-18 and at the follow up visit. |