Healthy Participants
Conditions
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.
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
Sponsors
H. Lundbeck A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Parts A and B: Terminal Elimination Half-life for Lu AH69593 (t1/2) | Up to Day 13 |
Contacts
CONTACTEmail contact via H. Lundbeck A/S
STUDY_DIRECTOREmail contact via H. Lundbeck A/S H. Lundbeck A/S
H. Lundbeck A/S
Outcome results
None listed