Testing Lu AH69593 for safety and tolerance in healthy adults and people with narcolepsy
Official 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
Run by H. Lundbeck A/S · NCT07613710 · Data updated 2026-11-12
This study tests whether Lu AH69593 is safe and well tolerated in adults, including those with narcolepsy, and looks at how the body processes the drug with and without food.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | H. Lundbeck A/S Industry-sponsored |
| Locations | 2 sites (Helsinki and 1 other locations) |
| Status | Recruiting |
| Started | June 13, 2025 |
| Main results expected | February 9, 2027 |
| Study ends | February 16, 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07613710 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–55 (or 64 for Part C) with BMI within specified ranges, a normal circadian rhythm, and stable vital signs, including those with narcolepsy or healthy volunteers as defined by Part A-D criteria.
✕Probably not a fit
Participants outside the BMI, age, or circadian rhythm criteria or those without narcolepsy may not experience direct benefit from the drug.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 interventional trial evaluates the safety and tolerability of Lu AH69593 in adults who are healthy or have narcolepsy. It also examines pharmacokinetics, comparing drug processing with and without food. The study includes multiple parts with specific inclusion criteria such as age ranges, BMI ranges, resting heart rate, and circadian rhythm considerations. Participants may receive Lu AH69593 or placebo, and enrollment is conducted at several clinical sites in Finland under lead sponsor H. Lundbeck A/S. Outcomes focus on safety signals, tolerability, and how food intake affects drug disposition.
Why it matters
Potential benefit: If successful, the study could establish a safe starting profile for Lu AH69593 and guide dosing strategies for future narcolepsy trials.
How similar studies have gone: Phase 1 trials of similar compounds often establish safety and pharmacokinetics; this study follows that established approach but the specific compound is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Terveystalo Helsinki, Sleep Clinic
Helsinki, Finland Recruiting -
CRST, Clinical Research Services Turku
Turku, Finland Completed
Study contacts
- Study coordinator: Email contact via H. Lundbeck A/S
- Email: HQ_Medinfo@Lundbeck.com
- Phone: +45 36301311
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
HBS-301 for Narcolepsy: daily wakefulness and sleepiness improvement in adults
This Phase 3 study tests HBS-301 vs placebo in adults with narcolepsy to see if it helps with daytime sleepiness, cataplexy, sleepiness, and fatigue.
-
Expanded-dosing Xywav vs placebo in narcolepsy and IH
This study tests whether expanded nightly dosing of Xywav helps adults with narcolepsy or idiopathic hypersomnia, compared with placebo.
-
Samelisant for Narcolepsy: A Phase 3 Test for EDS and Cataplexy
This phase 3 study tests whether Samelisant can reduce daytime sleepiness and cataplexy in adults with narcolepsy.
-
E2086 for adults with narcolepsy: find the best dose compared with placebo
This study tests different doses of E2086 against placebo in adults with narcolepsy to see if it reduces daytime sleepiness.
-
Exploring the effects of light and electrical stimulation on sleep disorders
This study is testing if light therapy and brain stimulation can help people with sleep disorders like insomnia and narcolepsy get better sleep.
-
Registry to evaluate the safety of SUNOSI during pregnancy
This study is trying to see if the medication SUNOSI is safe for pregnant women who have narcolepsy or sleep apnea and how it affects their babies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.