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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511073-29-00 | EU Trial (CTIS) Number |
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The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo | Experimental | Participants will receive single oral dose of Lu AH69593 or placebo. |
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| Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo | Experimental | Participants will receive Lu AH69593 or placebo orally for 10 days. |
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| Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593 | Experimental | Participants will receive Lu AH69593 orally for 84 days. |
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| Part D (Food Effect in Healthy Participants): Lu AH69593 | Experimental | Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AH69593 | Drug | Lu AH69593 will be administered per schedule specified in the arm description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline up to Day 90 | |
| Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness) | Baseline up to Day 84 | |
| Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli | Baseline, up to Day 11 | |
| PVT Parameter - Change From Baseline in Number of Errors of Omission | Baseline, up to Day 11 | |
| PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus) | Baseline, up to Day 11 | |
| Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to Day 90 | |
| Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593 | Up to 84 days | |
| Maximum Observed Plasma Concentration (Cmax) of Lu AH69593 | Up to 84 days | |
| Time to Reach Cmax (Tmax) of Lu AH69593 | Up to 84 days | |
| AUC From Time Zero to Infinity (AUC0-inf) |
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Key Inclusion Criteria:
For all participants in any trial Part (A, B, C and D):
Specifically for participants in trial Part A, B, and D:
Specifically for participants in trial Part C:
Key Exclusion Criteria:
For all participants in any trial Part (A, B, C and D):
Specifically for participants in trial Part A, B and D:
Specifically for Participants in trial Part B and C:
Specifically for participants in trial Part C:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Contact | +45 36301311 | HQ_Medinfo@Lundbeck.com |
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terveystalo Helsinki, Sleep Clinic | Recruiting | Helsinki | 00380 | Finland | ||
| CRST, Clinical Research Services Turku |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Placebo | Drug | Placebo will be administered per schedule specified in the arm description. |
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| Up to 6 days |
| Active, not recruiting |
| Turku |
| 20520 |
| Finland |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |