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

NCT07613710 | Recruiting Phase 1

• 2 other identifiers: 20653A2024-511073-29-00
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (4)

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.

Drug: Lu AH69593; Drug: Placebo

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.

Drug: Lu AH69593; Drug: Placebo

Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593

EXPERIMENTAL

Participants will receive Lu AH69593 orally for 84 days.

Drug: Lu AH69593

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.

Drug: Lu AH69593

Interventions

Lu AH69593 DRUG

Lu AH69593 will be administered per schedule specified in the arm description.

Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo; Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo; Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593; Part D (Food Effect in Healthy Participants): Lu AH69593

Placebo DRUG

Placebo will be administered per schedule specified in the arm description.

Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo; Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• The participant is ≥18 and ≤55 years of age at the Screening Visit.
• 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.
• The participant is ≥18 and ≤64 years of age at the Screening Visit.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (2)

Terveystalo Helsinki, Sleep Clinic

Helsinki, 00380, Finland

RECRUITING

CRST, Clinical Research Services Turku

Turku, 20520, Finland

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start: June 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

FI (2)