- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07613710
A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Email contact via H. Lundbeck A/S
- Telefonnummer: +45 36301311
- E-mail: HQ_Medinfo@Lundbeck.com
Studiesteder
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-
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Helsinki, Finland, 00380
- Rekruttering
- Terveystalo Helsinki, Sleep Clinic
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Turku, Finland, 20520
- Rekruttering
- CRST, Clinical Research Services Turku
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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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.
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Placebo vil blive administreret i henhold til skema specificeret i armbeskrivelsen.
Lu AH69593 will be administered per schedule specified in the arm description.
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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.
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Placebo vil blive administreret i henhold til skema specificeret i armbeskrivelsen.
Lu AH69593 will be administered per schedule specified in the arm description.
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Eksperimentel: Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593
Participants will receive Lu AH69593 orally for 84 days.
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Lu AH69593 will be administered per schedule specified in the arm description.
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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.
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Lu AH69593 will be administered per schedule specified in the arm description.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Baseline up to Day 90
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Baseline up to Day 90
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Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
Tidsramme: Baseline up to Day 84
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Baseline up to Day 84
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Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
Tidsramme: Baseline, up to Day 11
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Baseline, up to Day 11
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PVT Parameter - Change From Baseline in Number of Errors of Omission
Tidsramme: Baseline, up to Day 11
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Baseline, up to Day 11
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PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
Tidsramme: Baseline, up to Day 11
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Baseline, up to Day 11
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Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Baseline up to Day 90
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Baseline up to Day 90
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Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593
Tidsramme: Up to 84 days
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Up to 84 days
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Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Tidsramme: Up to 84 days
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Up to 84 days
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Time to Reach Cmax (Tmax) of Lu AH69593
Tidsramme: Up to 84 days
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Up to 84 days
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AUC From Time Zero to Infinity (AUC0-inf)
Tidsramme: Up to 6 days
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Up to 6 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Email contact via H. Lundbeck A/S, H. Lundbeck A/S
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20653A
- 2024-511073-29-00 (Ctis)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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