A Phase 1 interventional study of Lu AH69593 and Placebo in Narcolepsy, sponsored by H. Lundbeck A/S. Recruiting at 2 sites in Finland. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment
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.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 104 is above the median of 78 across 114 interventional studies indexed under Narcolepsy.
Browse Narcolepsy studies →H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
For all participants in any trial Part (A, B, C and D):
Specifically for participants in trial Part A, B, and D:
Specifically for participants in trial Part C:
Key Exclusion Criteria:
For all participants in any trial Part (A, B, C and D):
Specifically for participants in trial Part A, B and D:
Specifically for Participants in trial Part B and C:
Specifically for participants in trial Part C:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive single oral dose of Lu AH69593 or placebo.
Drug: Lu AH69593 · Drug: Placebo
Participants will receive Lu AH69593 or placebo orally for 10 days.
Drug: Lu AH69593 · Drug: Placebo
Participants will receive Lu AH69593 orally for 84 days.
Drug: Lu AH69593
Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition.
Drug: Lu AH69593
Lu AH69593 will be administered per schedule specified in the arm description.
Placebo will be administered per schedule specified in the arm description.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 90
Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
Time frame: Baseline up to Day 84
Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
Time frame: Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Omission
Time frame: Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
Time frame: Baseline, up to Day 11
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
Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593
Time frame: Up to 84 days
Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Time frame: Up to 84 days
Time to Reach Cmax (Tmax) of Lu AH69593
Time frame: Up to 84 days
AUC From Time Zero to Infinity (AUC0-inf)
Time frame: Up to 6 days
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