A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy

Sponsor
H. Lundbeck A/S
Study ID
NCT07613710
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Lu AH69593 — DRUG
    Lu AH69593 will be administered per schedule specified in the arm description.
  • Placebo — DRUG
    Placebo will be administered per schedule specified in the arm description.

Study Details

The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.

Key Dates

Start date
Jun 13, 2025
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Dec 18, 2026

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo
    Participants will receive single oral dose of Lu AH69593 or placebo.
  • Experimental: Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo
    Participants will receive Lu AH69593 or placebo orally for 10 days.
  • Experimental: Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593
    Participants will receive Lu AH69593 orally for 84 days.
  • Experimental: Part D (Food Effect in Healthy Participants): Lu AH69593
    Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 90 ]

Central Contacts

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