Recruiting
Phase 1

Lu AH69593 with Itraconazole & Carbamazepine

Sponsor:

H. Lundbeck A/S

Code:

NCT07775261

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Lu AH69593

Itraconazole

Carbamazepine

Midazolam

Study Details

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. 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.

Conditions

Healthy Participants

Study ID

NCT07775261

Start date

Aug 27, 2026

Status verified date

Oct, 2026

Completion date

Nov 6, 2026

Anticipated

Primary completion date

Nov 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

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.

Study Design

Enrollment

46 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Lu AH69593 + Itraconazole

experimental: Part B: Lu AH69593 + Carbamazepine

experimental: Part C: Lu AH69593 + Midazolam

Interventions

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

Primary outcome measure

  • 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 ]
  • Parts A and B: Maximum Observed Plasma Concentration (Cmax) of Lu AH69593 [ Time Frame: Up to Day 13 ]
  • Part C: (AUC0-inf) of Midazolam [ Time Frame: Up to Day 9 ]
  • Part C: Cmax of Midazolam [ Time Frame: Up to Day 9 ]

Central Contacts and Locations

Central contacts

Email contact via H. Lundbeck A/S

+45 36301311HQ_Medinfo@Lundbeck.com

Locations

Fortrea Clinical Research Unit Ltd (Labcorp Clinical Research Unit Limited)

Recruiting

Madison, Wisconsin, United States, 53704-2526

More Information

Sponsor

H. Lundbeck A/S

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by H. Lundbeck A/S on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.