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Clinical Trials/NCT07775261
NCT07775261Not yet recruitingPhase 1

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

H. Lundbeck A/S0 sites46 target enrollmentStarted: August 27, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
46
Primary Endpoint
Parts A and B: Area Under the Lu AH69593 Plasma-concentration-time Curve from Zero to Infinity (AUC0-inf)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

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.
  • •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.

Arms & Interventions

Part B: Lu AH69593 + Carbamazepine

Experimental

Intervention: Carbamazepine (Drug)

Part A: Lu AH69593 + Itraconazole

Experimental

Intervention: Lu AH69593 (Drug)

Part B: Lu AH69593 + Carbamazepine

Experimental

Intervention: Lu AH69593 (Drug)

Part C: Lu AH69593 + Midazolam

Experimental

Intervention: Lu AH69593 (Drug)

Part A: Lu AH69593 + Itraconazole

Experimental

Intervention: Itraconazole (Drug)

Part C: Lu AH69593 + Midazolam

Experimental

Intervention: Midazolam (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 25)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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