A Phase 1 interventional study of Lu AH69593 and Itraconazole in Healthy Participants, sponsored by H. Lundbeck A/S. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment
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
H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Additional protocol-defined criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lu AH69593 · Drug: Itraconazole
Drug: Lu AH69593 · Drug: Carbamazepine
Drug: Lu AH69593 · Drug: Midazolam
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: 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)
Time frame: Up to Day 13
Parts A and B: Time to Maximum Observed Plasma Concentration (Tmax) of Lu AH69593
Time frame: Up to Day 13
Parts A and B: Apparent Oral Clearance for Lu AH69593 (CL/F)
Time frame: Up to Day 13
Parts A and B: Apparent Volume of Distribution for Lu AH69593 (Vz/F)
Time frame: Up to Day 13
Parts A and B: Terminal Elimination Half-life for Lu AH69593 (t1/2)
Time frame: Up to Day 13
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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