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Can a new drug play well with others? a trial puts it to the test

NCT ID NCT07775261

Knowledge-focused Sponsor: H. Lundbeck A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing an experimental drug called Lu AH69593 in healthy adults to understand how it interacts with other medications. It will look at how the body absorbs and processes Lu AH69593 when taken alone or with other drugs that affect liver enzymes. The goal is to gather safety and dosing information for future studies.

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, an experimental drug, tested with itraconazole, carbamazepine, and midazolam
What this could lead to
If successful, this could help determine safe dosing and potential drug interactions for future studies of Lu AH69593.
What could go wrong
This is an early-stage trial in a small number of healthy volunteers, so results may not predict effects in patients or real-world use.

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 46 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

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 55 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: * The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests. * The participant is willing and able to attend trial appointments within the specified time windows. * The participant is willing to be an inpatient from the Baseline Visit to the Completion Visit. Key Exclusion Criteria: * The participant has taken any investigational medicinal product (IMP) \<2 months or \<5 halflives of that product, whichever is longer, prior to the first dose of IMP. * The participant has had, in the opinion of the investigator, a clinically significant illness from which he/she recovered \<4 weeks prior to the first dose of IMP. * The participant has or has had, in the opinion of the investigator, any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. * For Part B only: the participant tests positive for HLA-B\*15:02 or HLA-A\*31:01 allele. 3. * For Part B only: the participant has a personal or family history of Stevens-Johnson syndrome or toxic epidermal necrolysis. Additional protocol-defined criteria apply.

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As listed by the trial registrant

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

Healthy participants

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 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 ↗

  3. 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: •••••@•••••

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