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Not yet recruitingNCT07775261Updated Aug 20, 2026

A Trial of Lu AH69593 in Healthy Participants

A Phase 1 interventional study of Lu AH69593 and Itraconazole in Healthy Participants, sponsored by H. Lundbeck A/S. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

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.
02

Conditions studied

  • Healthy Participants
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Part A: Lu AH69593 + Itraconazole

    Drug: Lu AH69593 · Drug: Itraconazole

  • Experimental
    Part B: Lu AH69593 + Carbamazepine

    Drug: Lu AH69593 · Drug: Carbamazepine

  • Experimental
    Part C: Lu AH69593 + Midazolam

    Drug: Lu AH69593 · Drug: Midazolam

Interventions

  • DrugLu AH69593

    Specified dose on specified days

  • DrugItraconazole

    Specified dose on specified days

  • DrugCarbamazepine

    Specified dose on specified days

  • DrugMidazolam

    Specified dose on specified days

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07775261
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Aug 27, 2026 (estimated)
Primary completion
Nov 4, 2026 (estimated)
Completion
Nov 6, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Email contact via H. Lundbeck A/S
Contact
HQ_Medinfo@Lundbeck.com
+45 36301311
Email contact via H. Lundbeck A/S H. Lundbeck A/S
study director · H. Lundbeck A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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