A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
← catalyst calendarNCT07613710 · readout in 174 d
Sponsored by H. Lundbeck A/S (industry) · HLUN-B.CO — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
104estimated
Sites
2
Country
Finland
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-13 | actual | When the study began enrolling |
| Primary completion | 2027-02-09 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-16 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Narcolepsy
Interventions
- Drug: Lu AH69593
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
measured Baseline up to Day 90
Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
measured Baseline up to Day 84
Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
measured Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Omission
measured Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
measured Baseline, up to Day 11
Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
measured Baseline up to Day 90
Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593
measured Up to 84 days
Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
measured Up to 84 days
Time to Reach Cmax (Tmax) of Lu AH69593
measured Up to 84 days
AUC From Time Zero to Infinity (AUC0-inf)
measured Up to 6 days
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