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NCT Number: NCT07775261

A Trial of Lu AH69593 in Healthy Participants

This trial will evaluate the effects of itraconazole (Part A) and, carbamazepine (Part B) on Lu AH69593, and the effect of Lu AH69593 on midazolam (Part C) in adult healthy participants. The main goals of this trial are to learn about

1. the effect of other medicines on Lu AH69593 2. the pharmacokinetic parameters of Lu AH69593 (how the drug is absorbed, distributed, and processed by the body), and 3. the safety and tolerability of Lu AH69593.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AH69593

Drug

Specified dose on specified days

Itraconazole

Drug

Specified dose on specified days

carbamazepine

Drug

Specified dose on specified days

midazolam

Drug

Specified dose on specified days

Primary outcomes

  1. Parts A and B: Area Under the Lu AH69593 Plasma-concentration-time Curve from Zero to Infinity (AUC0-inf)

    Time frame: Up to Day 13

  2. Parts A and B: Maximum Observed Plasma Concentration (Cmax) of Lu AH69593

    Time frame: Up to Day 13

  3. Part C: (AUC0-inf) of Midazolam

    Time frame: Up to Day 9

  4. Part C: Cmax of Midazolam

    Time frame: Up to Day 9

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Day 25

  2. Parts A and B: Area Under the Lu AH69593 Plasma Concentration-time Curve From Zero to Last Quantifiable Time Point (AUC0-t)

    Time frame: Up to Day 13

  3. Parts A and B: Time to Maximum Observed Plasma Concentration (Tmax) of Lu AH69593

    Time frame: Up to Day 13

  4. Parts A and B: Apparent Oral Clearance for Lu AH69593 (CL/F)

    Time frame: Up to Day 13

  5. Parts A and B: Apparent Volume of Distribution for Lu AH69593 (Vz/F)

    Time frame: Up to Day 13

  6. Parts A and B: Terminal Elimination Half-life for Lu AH69593 (t1/2)

    Time frame: Up to Day 13

Study contacts

Contact information is provided by the study sponsor or research team.

Email contact via H. Lundbeck A/S

CONTACT

[email protected]

+45 36301311

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Fixed-sequence Crossover Trial Investigating the Effect of CYP3A4/5 Modulation on the Pharmacokinetics, Safety and Tolerability of Lu AH69593 and the Effect of Lu AH69593 on the Pharmacokinetics of a CYP3A4/5 Substrate in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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