NarcolepsyPhase 1NCT07613710
A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
A Phase 1 study testing Lu AH69593 in people with Narcolepsy, run by H. Lundbeck A/S at 2 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Lu AH69593
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesFinland
- Study dates
- 13 Jun 2025to 16 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 1 recruiting
- Recruiting
Terveystalo Helsinki, Sleep Clinic
Helsinki, 00380
- Completed
CRST, Clinical Research Services Turku
Turku, 20520
About this study
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
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.
- Conditions
- Narcolepsy
- Being tested
- Lu AH69593, Placebo
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AH69593Drug
Lu AH69593 will be administered per schedule specified in the arm description.
PlaceboDrug
Placebo will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo | Experimental | Participants will receive single oral dose of Lu AH69593 or placebo. Receives: Drug: Lu AH69593; Drug: Placebo |
| Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo | Experimental | Participants will receive Lu AH69593 or placebo orally for 10 days. Receives: Drug: Lu AH69593; Drug: Placebo |
| Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593 | Experimental | Participants will receive Lu AH69593 orally for 84 days. Receives: Drug: Lu AH69593 |
| Part D (Food Effect in Healthy Participants): Lu AH69593 | Experimental | Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition. Receives: Drug: Lu AH69593 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start13 Jun 2025
- Primary completion9 Feb 2027 (estimated)
- Study completion16 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613710
- Sponsor's protocol ID
- 20653A
- Other IDs
- 2024-511073-29-00
- Status last verified
- Aug 2026
- First submitted
- 15 May 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07613710
- Acronym / sponsor ID
- 20653A
- Conditions
- Narcolepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 16 Feb 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo | Experimental | Drug: Lu AH69593, Drug: PlaceboParticipants will receive single oral dose of Lu AH69593 or placebo. |
| Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo | Experimental | Drug: Lu AH69593, Drug: PlaceboParticipants will receive Lu AH69593 or placebo orally for 10 days. |
| Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593 | Experimental | Drug: Lu AH69593Participants will receive Lu AH69593 orally for 84 days. |
| Part D (Food Effect in Healthy Participants): Lu AH69593 | Experimental | Drug: Lu AH69593Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.
- 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.
- The participant has a BMI ≥18.5 and ≤35 kg/m^2 at the Screening Visit.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AH69593Lu AH69593 will be administered per schedule specified in the arm description. | Drug | Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo, Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo, Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593, Part D (Food Effect in Healthy Participants): Lu AH69593 |
| PlaceboPlacebo will be administered per schedule specified in the arm description. | Drug | Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo, Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AH69593 in people with Narcolepsy, run by H. Lundbeck A/S at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Email contact via H. Lundbeck A/S (+45 36301311, HQ_Medinfo@Lundbeck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 90). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.