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The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD4316 following oral administration of single and multiple doses to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: single ascending dose | Placebo Comparator | AZD4316: single oral dose, with 1 group with/without food |
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| Part B: multiple ascending dose | Placebo Comparator | AZD4316: multiple oral doses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4316 | Drug | Single oral doses of AZD4316 suspension in the fasted state. In one group in Part A, subjects will receive a second dose of AZD4316 in the fed state (within 30 min after receiving a high fat breakfast) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | from screening period to follow-up | |
| Assesment of vital signs (blood pressure, pulse and temperature) | Frequent assessments will be made for each subject from the screening period to follow up | from screening period to follow-up |
| Assessment of laboratory variables and physical examinations | Frequent assessments will be made for each subject from the screening period to follow up | from screening period to follow-up |
| Assessment of Electrocardiogram (ECG) variables | Frequent assessments will be made for each subject from the screening period to follow up | from screening period to follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables of AZD4316 by assessment of drug concentrations in plasma and urine | Serial blood samples and urine collection for PK evaluation throughout the period of admission and up to the time of the follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Dereck Tait | Arrow Therapeutics | Study Director |
| Dr Darren Wilbraham | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| AZD4316 | Drug | Multiple oral doses of AZD4316 suspension. It's planned that doses will be administered in the fasted state, however, if in Part A it's shown that food increases absorption of AZD4316, then doses will be administered after a meal. |
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| Placebo | Other | Placebo to match AZD4316 |
|