Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

8. juni 2026 opdateret af: H. Lundbeck A/S

Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single- and Multiple-ascending-dose Trial Investigating Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Participants, Including Open-label Cohorts to Explore Pharmacodynamic Properties in Participants With Narcolepsy, and Food Effect in Healthy Participants

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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Helsinki, Finland, 00380
        • Rekruttering
        • Terveystalo Helsinki, Sleep Clinic
      • Turku, Finland, 20520
        • Rekruttering
        • CRST, Clinical Research Services Turku

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Key Inclusion Criteria:

For all participants in any trial Part (A, B, C and D):

  • The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.

Specifically for participants in trial Part A, B, and D:

  • The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) at the Screening Visit.
  • The participant has a normal circadian rhythm, defined as a person who usually wakes up between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.
  • The participant is ≥18 and ≤55 years of age at the Screening Visit.

Specifically for participants in trial Part C:

  • The participant has a BMI ≥18.5 and ≤35 kg/m^2 at the Screening Visit.
  • The participant has NT1, diagnosed according to International Classification of Sleep Disorders, 3rd edition criteria, with a history of disease diagnosis >3 months prior to the Screening Visit.
  • The participant is ≥18 and ≤64 years of age at the Screening Visit.

Key Exclusion Criteria:

For all participants in any trial Part (A, B, C and D):

  • The participant has previously been enrolled in this trial.
  • The participant has previously been dosed with Lu AH69593.
  • The participant has participated in a clinical trial <30 days prior to the Screening Visit.
  • The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
  • The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of investigational medicinal product (IMP).
  • The participant has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
  • The participant trains/exercises intensively, for example, for a marathon or triathlon, or at a competitive level.

Specifically for participants in trial Part A, B and D:

  • The participant has had a clinically significant illness from which he/she recovered <4 weeks prior to the first dose of IMP.

Specifically for Participants in trial Part B and C:

  • The participant is at significant risk of suicide based on medical history, mental status, investigator judgement, or the C-SSRS answer of 'yes' to suicidal ideation question 4 or 5 or 'yes' to suicidal behaviour, within the last 6 months on the C-SSRS at the Screening Visit or 'Since last visit' at the Baseline Visit Day -1.

Specifically for participants in trial Part C:

  • The participant has any other disorder for which the treatment takes priority over treatment of narcolepsy or is likely to interfere with trial treatment or impair treatment compliance.
  • The participant has a current medical disorder, other than NT1, associated with excessive daytime sleepiness (EDS).

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive single oral dose of Lu AH69593 or placebo.
Placebo vil blive administreret i henhold til skema specificeret i armbeskrivelsen.
Lu AH69593 will be administered per schedule specified in the arm description.
Eksperimentel: Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive Lu AH69593 or placebo orally for 10 days.
Placebo vil blive administreret i henhold til skema specificeret i armbeskrivelsen.
Lu AH69593 will be administered per schedule specified in the arm description.
Eksperimentel: Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593
Participants will receive Lu AH69593 orally for 84 days.
Lu AH69593 will be administered per schedule specified in the arm description.
Eksperimentel: Part D (Food Effect in Healthy Participants): Lu AH69593
Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition.
Lu AH69593 will be administered per schedule specified in the arm description.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Baseline up to Day 90
Baseline up to Day 90
Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
Tidsramme: Baseline up to Day 84
Baseline up to Day 84
Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
Tidsramme: Baseline, up to Day 11
Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Omission
Tidsramme: Baseline, up to Day 11
Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
Tidsramme: Baseline, up to Day 11
Baseline, up to Day 11
Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Baseline up to Day 90
Baseline up to Day 90
Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593
Tidsramme: Up to 84 days
Up to 84 days
Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Tidsramme: Up to 84 days
Up to 84 days
Time to Reach Cmax (Tmax) of Lu AH69593
Tidsramme: Up to 84 days
Up to 84 days
AUC From Time Zero to Infinity (AUC0-inf)
Tidsramme: Up to 6 days
Up to 6 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. juni 2025

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

18. december 2026

Datoer for studieregistrering

Først indsendt

15. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 20653A
  • 2024-511073-29-00 (Ctis)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo

Abonner