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A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.
Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.
For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG06466 - Sequence 1 | Experimental | Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast. |
|
| Lu AG06466 - Sequence 2 | Experimental | Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 | Drug | hard capsules, orally, single doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf) Lu AG06466 | Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 |
| AUC(0-inf) Lu AG06988 | Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 |
| Cmax Lu AG06466 | Maximum observed plasma concentration (Cmax) of Lu AG06466 | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 |
| Cmax Lu AG06988 | Maximum observed plasma concentration (Cmax) of Lu AG06988 | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 |
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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 |
|---|---|---|---|---|---|---|
| US1517 | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | 200 and 300 mg, capsules, orally |
|
| D010879 |
| Piperazines |