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The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Dose of Lu AG06474 or Placebo | Experimental | Participants will receive single oral dose of Lu AG06474 or placebo. |
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| Part B: Repeated Dose of Lu AG06474 and Food Interaction | Experimental | Participants will receive a single oral dose of Lu AG06474 in each dosing period (Period 1, 2, and 3) in the following sequence: Sequence B1: Fed - Fasting- Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06474 | Drug | solution, orally (Parts A and B) |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Number of participants With Treatment-Emergent Adverse Events | From Baseline to Day 8 | |
| Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1 | Day 1 | |
| Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1 | Pre-dose Baseline (Day -1), Day 1 | |
| Part A: Bond-Lader VAS Dimension Scores at Day 4 | Day 4 | |
| Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4 | Pre-dose Baseline (Day -1), Day 4 | |
| Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA]) | From pre-dose to Day 4 | |
| Parts A and B: AUC0-inf of Lu AG06474 | Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf) | From pre-dose to Day 4 |
| Parts A and B: Cmax of Lu AG06474 | Maximum observed plasma concentration for Lu AG06474 | From pre-dose to Day 4 |
| Parts A and B: Tmax of Lu AG06474 | Nominal time corresponding to the occurrence of Cmax of Lu AG06474 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Miami | Miami | Florida | 33126 | United States |
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Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
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| Placebo | Drug | solution, orally (Part A only) |
|
| From pre-dose to Day 4 |
| Part A: t1/2 of Lu AG06474 | Apparent elimination half-life of Lu AG06474 | From pre-dose to Day 4 |