Actively Recruiting
Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Adults and Adults With Narcolepsy Including Food Effect Assessment
Led by H. Lundbeck A/S · Updated on 2026-05-29
104
Participants Needed
2
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of the drug Lu AH69593 in adults who are either healthy or have narcolepsy. The trial also aims to understand how the body processes Lu AH69593 when taken with or without food. This is a Phase 1 randomized, double-blind, placebo-controlled study sponsored by H. Lundbeck A/S, focusing on safety and pharmacokinetics.
CONDITIONS
Brief Title
A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 55 years
- Resting supine pulse between 45 and 100 beats per minute at screening and baseline
- Body mass index (BMI) between 18.5 and 30 kg/m² for healthy participants (Parts A, B, D)
- Normal circadian rhythm with usual wake time between 6:00 and 9:00 a.m. and sleep time between 9:00 p.m. and midnight for Parts A, B, D
- BMI between 18.5 and 35 kg/m² for participants with narcolepsy type 1 (Part C)
- Diagnosis of narcolepsy type 1 according to International Classification of Sleep Disorders, 3rd edition, with diagnosis over 3 months before screening (Part C)
You will not qualify if you...
- Previous enrollment in this trial
- Previous dosing with Lu AH69593
- Participation in any clinical trial within 30 days prior to screening
- Pregnancy, breastfeeding, intent to become pregnant, or unwillingness to use effective contraception
- History of cancer not in remission for over 5 years (except certain skin and cervical cancers)
- Shift work or travel across over 3 time zones within 2 weeks before first dose
- Intensive training or competitive exercise such as marathon or triathlon
- Clinically significant illness recovered less than 4 weeks before first dose (Parts A, B, D)
- Significant risk of suicide based on medical history or assessment within last 6 months (Parts B, C)
- Other disorders requiring priority treatment over narcolepsy or interfering with treatment compliance (Part C)
- Medical disorders causing excessive daytime sleepiness other than narcolepsy type 1 (Part C)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 84 days depending on study part
Participants receive Lu AH69593 or placebo orally according to their assigned study part, including single or multiple dosing schedules.
1 to 10 daily visits depending on dosing schedule
Duration - Up to 6 weeks after last dose
Participants are monitored for safety and tolerability after treatment completion.
Approximately 1 to 2 visits
Trial Site Locations
Total: 2 locations
1
Terveystalo Helsinki, Sleep Clinic
Helsinki, Finland, 00380
Actively Recruiting
2
CRST, Clinical Research Services Turku
Turku, Finland, 20520
Actively Recruiting
Research Team
E
Email contact via H. Lundbeck A/S
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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