A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy

Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single- and Multiple-ascending-dose Trial Investigating Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Participants, Including Open-label Cohorts to Explore Pharmacodynamic Properties in Participants With Narcolepsy, and Food Effect in Healthy Participants

The purpose of the trial is to determine that Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.

Study Overview

• Status: Recruiting
• Conditions: Narcolepsy
• Intervention / Treatment: Drug: Placebo; Drug: Lu AH69593

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Email contact via H. Lundbeck A/S; Phone Number: +45 36301311; Email: HQ_Medinfo@Lundbeck.com

Study Locations

• Finland
  • Helsinki, Finland, 00380
    • Recruiting
    • Terveystalo Helsinki, Sleep Clinic
  • Turku, Finland, 20520
    • Recruiting
    • CRST, Clinical Research Services Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

For all participants in any trial Part (A, B, C and D):

• The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.

Specifically for participants in trial Part A, B, and D:

• The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) at the Screening Visit.
• The participant has a normal circadian rhythm, defined as a person who usually wakes up between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.

Specifically for participants in trial Part C:

• The participant has a BMI ≥18.5 and ≤35 kg/m^2 at the Screening Visit.
• The participant has NT1, diagnosed according to International Classification of Sleep Disorders, 3rd edition criteria, with a history of disease diagnosis >3 months prior to the Screening Visit.

Key Exclusion Criteria:

For all participants in any trial Part (A, B, C and D):

• The participant has previously been enrolled in this trial.
• The participant has previously been dosed with Lu AH69593.
• The participant has participated in a clinical trial <30 days prior to the Screening Visit.
• The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
• The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of investigational medicinal product (IMP).
• The participant has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
• The participant trains/exercises intensively, for example, for a marathon or triathlon, or at a competitive level.

Specifically for participants in trial Part A, B and D:

• The participant has had a clinically significant illness from which he/she recovered <4 weeks prior to the first dose of IMP.

Specifically for Participants in trial Part B and C:

• The participant is at significant risk of suicide based on medical history, mental status, investigator judgement, or the C-SSRS answer of 'yes' to suicidal ideation question 4 or 5 or 'yes' to suicidal behaviour, within the last 6 months on the C-SSRS at the Screening Visit or 'Since last visit' at the Baseline Visit Day -1.

Specifically for participants in trial Part C:

• The participant has any other disorder for which the treatment takes priority over treatment of narcolepsy or is likely to interfere with trial treatment or impair treatment compliance.
• The participant has a current medical disorder, other than NT1, associated with excessive daytime sleepiness (EDS).

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo; Participants will receive single oral dose of Lu AH69593 or placebo.	Drug: Placebo; Placebo will be administered per schedule specified in the arm description.; Drug: Lu AH69593; Lu AH69593 will be administered per schedule specified in the arm description.
Experimental: Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo; Participants will receive Lu AH69593 or placebo orally for 10 days.	Drug: Placebo; Placebo will be administered per schedule specified in the arm description.; Drug: Lu AH69593; Lu AH69593 will be administered per schedule specified in the arm description.
Experimental: Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593; Participants will receive Lu AH69593 orally for 84 days.	Drug: Lu AH69593; Lu AH69593 will be administered per schedule specified in the arm description.
Experimental: Part D (Food Effect in Healthy Participants): Lu AH69593; Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition.	Drug: Lu AH69593; Lu AH69593 will be administered per schedule specified in the arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	Up to 6 days

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 18, 2026

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: 20653A; 2024-511073-29-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No