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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD5213 in healthy young and elderly Japanese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Each cohort will have 6 subjects that will receive AZD5213 |
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| Placebo | Placebo Comparator | Each cohort will have 2 subjects that will receive placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5213 | Drug | Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs). | Range of Days 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax. | Range of Days 1-12 | |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of fe. | Range of Days 1-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Märta Segerdahl, MD, PhD | AstraZeneca R&D, Södertälje | Study Director |
| Akimasa Watanabe, MD | Kyushu Clinical Pharmacology Research Clinic, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centre | Fukuoka | Japan |
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| Label | URL |
|---|---|
| D3030C00004\_Clinical\_Study\_Report\_Synopsis.pdf | View source |
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| Placebo | Drug | Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days |
|
| To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC. | Range of Days 1-12 |