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New narcolepsy drug enters first human safety tests

NCT ID NCT07613710

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This early-stage trial is testing a new drug called Lu AH69593 to see if it is safe and how the body handles it. The study includes healthy volunteers and people with narcolepsy. Researchers will monitor side effects and measure drug levels in the blood, including how food affects absorption.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lu AH69593
What this could lead to
If successful, this could point toward a new treatment option to help manage narcolepsy symptoms.
What could go wrong
This is a very early Phase 1 trial focused on safety, not effectiveness. The drug may not work or could have side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 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. 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. Key Exclusion Criteria: 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). * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CRST, Clinical Research Services Turku

    COMPLETED

    Turku, 20520, Finland

  • Terveystalo Helsinki, Sleep Clinic

    RECRUITING

    Helsinki, 00380, Finland

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