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The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAB | Experimental | AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast |
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| HBA | Experimental | AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast |
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| LAB | Experimental | AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast |
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| LBA | Experimental | AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0837 | Drug | Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation. | Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the PK of the intermediate metabolite AR-H069927XX | Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above. | |
| Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Edén Eden | Quintiles AB, Uppsala, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
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| ID | Term |
|---|---|
| C551586 | AZD 0837 |
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| AZD0837 | Drug | Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days |
|
| ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1. |
| Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4 | Once predose on day 1, session 1 and once predose on day 5, session 2 |