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The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women
This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
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| Part B group 1 | Experimental | Treatment period 1: Fasted + iv; Treatment period 2: Fasted; Treatment period 3: High-fat meal |
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| Part B group 2 | Experimental | Treatment period 1: High-fat meal; Treatment period 2: Fasted + iv; Treatment period 3: Fasted |
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| Part B group 3 | Experimental | Treatment period 1: Fasted; Treatment period 2: High-fat meal; Treatment period 3: Fasted + iv |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF11167 | Drug | Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations) |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Lu AF11167 | Maximum observed plasma concentration | From 0 to 48 hours |
| AUC(0-inf) of Lu AF11167 | Area under the plasma concentration time curve from zero to infinity | From 0 to 48 hours |
| Relative bioavailability F(rel) of Lu AF11167 | F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only) | From 0 to 48 hours |
| Absolute bioavailability F(abs) of Lu AF11167 | F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only) | From 0 to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Other in- and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient | Nottingham | United Kingdom |
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| [14C]-Lu AF11167 | Drug | single iv microdose administered as a 15 minutes infusion |
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| Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) | Drug | Single oral dose |
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