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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lu AH69593
DrugSpecified dose on specified days
Itraconazole
DrugSpecified dose on specified days
Carbamazepine
DrugSpecified dose on specified days
Midazolam
DrugSpecified dose on specified days
Treatment groups
46 Participants
are divided into 3 treatment groupsGroup A: Part A: Lu AH69593 + ItraconazoleExperimental treatment 2 interventions
Group B: Part B: Lu AH69593 + CarbamazepineExperimental treatment 2 interventions
Group C: Part C: Lu AH69593 + MidazolamExperimental treatment 2 interventions
Trial outcomes
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 132
Parts A and B: Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Time frame
Up to Day 133
Part C: (AUC0-inf) of Midazolam
Time frame
Up to Day 94
Part C: Cmax of Midazolam
Time frame
Up to Day 9Secondary outcomes
1
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame
Up to Day 252
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 133
Parts A and B: Time to Maximum Observed Plasma Concentration (Tmax) of Lu AH69593
Time frame
Up to Day 134
Parts A and B: Apparent Oral Clearance for Lu AH69593 (CL/F)
Time frame
Up to Day 13Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: