A Trial of Lu AH69593 in Healthy Participants

NCT07775261 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 21515A
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

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

  Up to Day 25

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

  Up to Day 13

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

  Up to Day 13

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

  Up to Day 13

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

  Up to Day 13

Study Arms (3)

Part A: Lu AH69593 + Itraconazole

EXPERIMENTAL

Drug: Lu AH69593; Drug: Itraconazole

Part B: Lu AH69593 + Carbamazepine

EXPERIMENTAL

Drug: Lu AH69593; Drug: Carbamazepine

Part C: Lu AH69593 + Midazolam

EXPERIMENTAL

Drug: Lu AH69593; Drug: Midazolam

Interventions

Lu AH69593 DRUG

Specified dose on specified days

Part A: Lu AH69593 + Itraconazole; Part B: Lu AH69593 + Carbamazepine; Part C: Lu AH69593 + Midazolam

Itraconazole DRUG

Specified dose on specified days

Part A: Lu AH69593 + Itraconazole

Carbamazepine DRUG

Specified dose on specified days

Part B: Lu AH69593 + Carbamazepine

Midazolam DRUG

Specified dose on specified days

Part C: Lu AH69593 + Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

MeSH Terms

Interventions

Itraconazole; Carbamazepine; Midazolam

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Officials

• Email contact via H. Lundbeck A/S H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 20, 2026
• Study Start: August 27, 2026
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08