RECRUITING Phase 1 ClinicalTrials.gov

A Trial of Lu AH69593 in Healthy Participants

Sponsor: H. Lundbeck A/S • ClinicalTrials.gov ID: NCT07775261

Registry updated: 2026-10-14

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Description

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.

Interventions

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

Eligibility criteria

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.

Conditions

Healthy Participants

Locations

Fortrea Clinical Research Unit Ltd (Labcorp Clinical Research Unit Limited) — Madison, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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