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| ID | Type | Description | Link |
|---|---|---|---|
| Pharmaceutical Profiles PL1168 |
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A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8566 | Drug | Single 6 mg oral solution dose | ||
| AZD8566 IV carbon labelled | Drug | Single 10 mcg intravenous carbon-14 microtracer dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food | Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events | Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events. | |
| Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Collier, Dr,MB, ChB | Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nottingham | United Kingdom |
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| Samples taken during visit 2, at up to 40 defined timepoints pre and post dose |
| Intravenous pharmacokinetics | Samples taken during visit 2, at up to 40 defined timepoints pre and post dose |