Actively Recruiting
Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Adults and Adults with Narcolepsy
Led by H. Lundbeck A/S · Updated on 2026-08-12
104
Participants Needed
2
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes Lu AH69593 in adults who are either healthy or have narcolepsy. The study aims to understand how this drug behaves with and without food, while monitoring its effects on alertness, mood, reaction times, and safety measures including adverse events and suicidal thoughts. This is a phase 1 trial sponsored by H. Lundbeck AS. Participants will be assigned to one of several groups receiving Lu AH69593 or a placebo. Some will receive a single oral dose, others will take the drug or placebo daily for 10 days, and some participants with narcolepsy will take the drug daily for 84 days. A separate group will receive two single doses under fasting or fed conditions to assess food effects. During the study, participants will undergo various assessments including reaction time tests, mood scales, and safety monitoring for adverse events and suicidal behavior over periods ranging up to 90 days. Blood samples will be taken to measure drug levels in the body. Visits will be scheduled according to the treatment part, and participants will be closely monitored throughout the trial period to evaluate safety and drug processing.
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 must have a resting supine pulse between 45 and 100 beats per minute at screening and baseline visits.
- For Parts A, B, and D: Participants must have a body mass index (BMI) between 18.5 and 30 kg/m² at screening.
- For Parts A, B, and D: Participants must have a normal circadian rhythm, waking between 6:00 and 9:00 a.m. and sleeping between 9:00 p.m. and midnight.
- For Parts A, B, and D: Participants must be between 18 and 45 years old at screening.
- For Part C: Participants must have a BMI between 18.5 and 35 kg/m² at screening.
- For Part C: Participants must have narcolepsy type 1 diagnosed more than 3 months prior to screening.
- For Part C: Participants must be between 18 and 64 years old at screening.
You will not qualify if you...
- Participants previously enrolled in this trial or previously dosed with Lu AH69593.
- Participants who participated in another clinical trial less than 30 days before screening.
- Participants who are pregnant, breastfeeding, or of childbearing potential not using adequate contraception.
- Participants with a history of cancer not in remission for more than 5 years, except certain skin cancers and treated cervical intraepithelial neoplasia.
- Participants who worked shifts, including night duty, or traveled across more than 3 time zones within 2 weeks before dosing.
- Participants who train or exercise intensively, such as for marathons or competitive sports.
- For Parts A, B, and D: Participants who had significant illness less than 4 weeks before dosing.
- For Parts B and C: Participants at significant risk of suicide based on medical history or recent assessments.
- For Part C: Participants with other disorders prioritizing treatment over narcolepsy or medical disorders causing excessive daytime sleepiness other than narcolepsy type 1.
Research Team
E
Email contact via H. Lundbeck A/S
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here