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To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7325 | Drug | Oral, day 1-12 |
| |
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite). | Blood samples will be taken during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine. | Blood samples will be taken during the study. | |
| Evaluation of the pharmacodynamic effects of AZD7325 | Test batteries will be performed at specified times both before and following study drug administration. |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Wilbraham, MBBS, DCPSA | Guy's Drug Research Unit Quintiles | Principal Investigator |
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| ID | Term |
|---|---|
| C576237 | 4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide |
| D008874 | Midazolam |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
single dose, twice during treatment |
|
| Caffeine | Drug | single dose, twice during treatment |
|
| To evaluate the pharmacokinetics of AZD7325 | Blood samples will be taken on Days 1, 11 and 12. |
| D006571 | Heterocyclic Compounds |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |