A Trial of Lu AH69593 in Healthy Participants

ConditionHealthy Participants

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorH. Lundbeck A/S

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

Lu AH69593
Itraconazole
Carbamazepine
Midazolam

Treatment groups

46 Participants

are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

H. Lundbeck A/S

Lead sponsor

Source ClinicalTrials.gov