Healthy ParticipantsPhase 1NCT07775261
A Trial of Lu AH69593 in Healthy Participants
A Phase 1 study testing Lu AH69593, Itraconazole and Carbamazepine in people with Healthy Participants, run by H. Lundbeck A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lu AH69593, Itraconazole and Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2026to 6 Nov 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit Ltd (Labcorp Clinical Research Unit Limited)
Madison, Wisconsin, 53704-2526
About this study
Official title: Interventional, Open-label, Fixed-sequence Crossover Trial Investigating the Effect of CYP3A4/5 Modulation on the Pharmacokinetics, Safety and Tolerability of Lu AH69593 and the Effect of Lu AH69593 on the Pharmacokinetics of a CYP3A4/5 Substrate in Healthy Participants
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
- the effect of other medicines on Lu AH69593
- the pharmacokinetic parameters of Lu AH69593 (how the drug is absorbed, distributed, and processed by the body), and
- the safety and tolerability of Lu AH69593.
- Conditions
- Healthy Participants
- Being tested
- Lu AH69593, Itraconazole, Carbamazepine, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AH69593Drug
Specified dose on specified days
ItraconazoleDrug
Specified dose on specified days
CarbamazepineDrug
Specified dose on specified days
MidazolamDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A: Lu AH69593 + Itraconazole | Experimental | Not described Receives: Drug: Lu AH69593; Drug: Itraconazole |
| Part B: Lu AH69593 + Carbamazepine | Experimental | Not described Receives: Drug: Lu AH69593; Drug: Carbamazepine |
| Part C: Lu AH69593 + Midazolam | Experimental | Not described Receives: Drug: Lu AH69593; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Area Under the Lu AH69593 Plasma-concentration-time Curve from Zero to Infinity (AUC0-inf)
Measured: Up to Day 13
Parts A and B: Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Measured: Up to Day 13
Part C: (AUC0-inf) of Midazolam
Measured: Up to Day 9
Part C: Cmax of Midazolam
Measured: Up to Day 9
Secondary outcomes (6)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: 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)
Measured: Up to Day 13
Parts A and B: Time to Maximum Observed Plasma Concentration (Tmax) of Lu AH69593
Measured: Up to Day 13
Parts A and B: Apparent Oral Clearance for Lu AH69593 (CL/F)
Measured: Up to Day 13
Parts A and B: Apparent Volume of Distribution for Lu AH69593 (Vz/F)
Measured: Up to Day 13
Parts A and B: Terminal Elimination Half-life for Lu AH69593 (t1/2)
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start27 Aug 2026
- Primary completion4 Nov 2026 (estimated)
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775261
- Sponsor's protocol ID
- 21515A
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No