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Recruiting Phase 1

A Trial of Lu AH69593 in Healthy Participants

NCT07775261 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2026-08-27
Last updated
2026-10-14

Condition(s) studied

Healthy Participants

Investigational drug(s) / intervention(s)

Lu AH69593Itraconazole →Carbamazepine →Midazolam →

Lu AH69593: Specified dose on specified days

Itraconazole: Specified dose on specified days

Carbamazepine: Specified dose on specified days

Midazolam: Specified dose on specified days

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Parts A and B: Area Under the Lu AH69593 Plasma-concentration-time Curve from Zero to Infinity (AUC0-inf) — Up to Day 13
  • Parts A and B: Maximum Observed Plasma Concentration (Cmax) of Lu AH69593 — Up to Day 13
  • Part C: (AUC0-inf) of Midazolam — Up to Day 9
  • Part C: Cmax of Midazolam — Up to Day 9

Trial sites (1)

FacilityCityRegionStatus
Fortrea Clinical Research Unit Ltd (Labcorp Clinical Research Unit Limited) Madison Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07775261 on ClinicalTrials.gov ↗ ← All trials in the USA