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The purpose of this study is to evaluate the effect of repeated doses of the drug Lu AG06466 on the exposure of metoprolol, midazolam and bupropion
On Day 1, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.
On Day 3, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.
On Days 5-18, subjects will be dosed with Lu AG06466 once daily.
On Day 15, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.
On Day 17, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG06466 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 | Drug | 10, 20, 30 mg/day oral capsules on Day 5-18 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-inf for midazolam | Area under the midazolam plasma concentration-time curve from zero to infinity | Day 1 and Day 15 |
| AUC 0-inf for metoprolol | Area under the metoprolol plasma concentration-time curve from zero to infinity | Day 1 and Day 15 |
| AUC 0-inf for bupropion | Area under the bupropion plasma concentration-time curve from zero to infinity | Day 3 and Day 17 |
| Cmax for midazolam | Maximum observed plasma concentration for midazolam | Day 1 and Day 15 |
| Cmax for metoprolol | Maximum observed plasma concentration for metoprolol | Day 1 and Day 15 |
| Cmax for bupropion | Maximum observed plasma concentration for bupropion | Day 3 and Day 17 |
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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 |
|---|---|---|---|---|---|---|
| Covance Dallas CRU | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D008790 | Metoprolol |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Other |
4 mg syrup, oral single dose on Day 1 and Day 15 |
|
| Metoprolol | Other | 100 mg tablets, oral single dose on Day 1 and Day 15 |
|
| Bupropion | Other | 100 mg tablets, oral single dose on Day 3 and Day 17 |
|
| D006571 | Heterocyclic Compounds |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D011427 | Propiophenones |
| D007659 | Ketones |