A Trial of Lu AH69593 in Healthy Participants

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
H. Lundbeck A/S
Study ID
NCT07775261
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Lu AH69593 — DRUG
    Specified dose on specified days
  • Itraconazole — DRUG
    Specified dose on specified days
  • Carbamazepine — DRUG
    Specified dose on specified days
  • Midazolam — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Aug 27, 2026
Status verified
Oct 2026
Primary completion
Nov 4, 2026
Completion
Nov 6, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Lu AH69593 + Itraconazole
  • Experimental: Part B: Lu AH69593 + Carbamazepine
  • Experimental: Part C: Lu AH69593 + Midazolam

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research Unit Ltd (Labcorp Clinical Research Unit Limited)MadisonWisconsin53704-2526-

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Fortrea Clinical Research Unit Ltd (Labcorp Clinical Research Unit Limited)· Madison, WI

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