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NCT Number: NCT07613710

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Terveystalo Helsinki, Sleep Clinic, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

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.

Treatment and study plan

Lu AH69593

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline up to Day 90

  2. Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)

    Time frame: Baseline up to Day 84

  3. Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli

    Time frame: Baseline, up to Day 11

  4. PVT Parameter - Change From Baseline in Number of Errors of Omission

    Time frame: Baseline, up to Day 11

  5. PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)

    Time frame: Baseline, up to Day 11

  6. Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline up to Day 90

  7. Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593

    Time frame: Up to 84 days

  8. Maximum Observed Plasma Concentration (Cmax) of Lu AH69593

    Time frame: Up to 84 days

  9. Time to Reach Cmax (Tmax) of Lu AH69593

    Time frame: Up to 84 days

  10. AUC From Time Zero to Infinity (AUC0-inf)

    Time frame: Up to 6 days

Study contacts

Contact information is provided by the study sponsor or research team.

Email contact via H. Lundbeck A/S

CONTACT

[email protected]

+45 36301311

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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