- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07693868
A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity
An NNC6022-0004 Single and Multiple Ascending Dose Study Investigating Safety, Tolerability, Pharmacokinetics, Food Effect and Target Engagement in Healthy Adults Including a Single Cohort in Adults Living With Obesity
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Novo Nordisk
- Telefonní číslo: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studijní místa
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Groningen, Holandsko, 9728 NZ
- ICON - location Groningen
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Male, or female of non-childbearing potential.
- For Parts A, B, C and D: Age 18-55 years (both inclusive) at the time of signing the informed consent.
For optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent.
-For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
For optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg/m^2 at screening, or if BMI is between 27.0 and <30.0 kg/m^2, waist to height ratio should be greater than (>)0.5.
- Body weight: ≥50.0 kilogram (kg) at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- For optional Part E only: hsCRP ≥2.00 and ≤8.00 milligrams per liter (mg/L) during screening period in 2 separate samples taken ≥4 days apart.
Exclusion Criteria:
- Known or suspected hypersensitivity to study intervention(s) or similar products.
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.
- Alanine Aminotransferase (ALT) > Upper limit of normal (ULN).
- Alkaline Phosphatase (ALP) > ULN.
- Aspartate aminotransferase (AST) > ULN.
- Total Bilirubin (TBL) > ULN.
- Creatinine > ULN.
- International normalized ratio (INR) > ULN.
- Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g/L).
hsCRP > 5.00 mg/L (males) and > 8.00 mg/L (females)*.
- applicable for Parts A, B, C and D and for optional Part E: hsCRP >8.00 mg/L.
- Use of prescription medicinal products or vaccines within 14 days before screening and/or non prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: NNC6022-0004
Participants will receive NNC6022-0004 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions.
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Participants will receive single dose of NNC6022-0004 administered orally in capsule form.
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Komparátor placeba: Placebo
Participants will receive placebo matched to NNC6022-0004 administered orally as a SAD, MAD, or under fed/fasted conditions.
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Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose
Časové okno: From pre-dose (Day 1) until visit 3 (Day 9)
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Measured as micromolar per hour (µM*h).
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From pre-dose (Day 1) until visit 3 (Day 9)
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Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose
Časové okno: From pre-dose (Day 1) until visit 3 (Day 9)
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Measured as micromolar (µM).
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From pre-dose (Day 1) until visit 3 (Day 9)
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Part B: Number of treatment emergent adverse events (TEAE)
Časové okno: From time of dosing (Day 1) to end of study visit (Day 14)
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Measured as number of events.
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From time of dosing (Day 1) to end of study visit (Day 14)
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Part C: Number of treatment emergent adverse events
Časové okno: From time of dosing (Day 1) to end of study visit (Day 41)
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Measured as number of events.
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From time of dosing (Day 1) to end of study visit (Day 41)
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Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose
Časové okno: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
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Measured as µM*h.
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From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
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Part E: Number of treatment emergent adverse events
Časové okno: From time of dosing (Day 1) to end of study visit (Day 13)
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Measured as number of events.
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From time of dosing (Day 1) to end of study visit (Day 13)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose
Časové okno: From pre-dose (Day 1) until visit 3 (Day 9)
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Measured as µM*h.
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From pre-dose (Day 1) until visit 3 (Day 9)
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Part A: Number of treatment emergent adverse events
Časové okno: From time of dosing (Day 1) to end of study visit (Day 9)
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Measured as number of events.
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From time of dosing (Day 1) to end of study visit (Day 9)
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Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose
Časové okno: From pre-dose (Day 1) until visit 3 (Day 9)
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Measured as µM*h.
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From pre-dose (Day 1) until visit 3 (Day 9)
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Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose
Časové okno: From pre-dose (Day 1) until visit 3 (Day 9)
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Measured as µM*h.
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From pre-dose (Day 1) until visit 3 (Day 9)
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Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose
Časové okno: From pre-dose (Day 1) until visit 3 (Day 9)
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Measured as µM.
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From pre-dose (Day 1) until visit 3 (Day 9)
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Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose
Časové okno: From dose (Day 1) until 72h post-dose
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Measured as proportion of dose.
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From dose (Day 1) until 72h post-dose
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Part C: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after the last dose
Časové okno: From pre-dose (Day 28) to tau after last dose (Day 29)
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Measured as µM*h.
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From pre-dose (Day 28) to tau after last dose (Day 29)
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Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose
Časové okno: From pre-dose (Day 28) until visit 3 (Day 35)
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Measured as µM.
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From pre-dose (Day 28) until visit 3 (Day 35)
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Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline
Časové okno: From pre-dose (Day 1) to tau after last dose (Day 29)
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Measured as ratio
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From pre-dose (Day 1) to tau after last dose (Day 29)
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Part D: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose
Časové okno: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
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Measured as µM*h.
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From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
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Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose
Časové okno: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
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Measured as µM.
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From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
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Part D: Number of treatment emergent adverse events
Časové okno: From time of dosing (Day 1) to end of visit (Day 16)
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Measured as number of events.
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From time of dosing (Day 1) to end of visit (Day 16)
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Part E: Ratio of plasma level at time tau after last dose to baseline (hsCRP)
Časové okno: From pre-dose (Day 1) to tau after last dose (Day 8)
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Measured as ratio.
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From pre-dose (Day 1) to tau after last dose (Day 8)
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Part E: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after last dose
Časové okno: From pre-dose (Day 7) to tau after last dose (Day 8)
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Measured as µM*h .
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From pre-dose (Day 7) to tau after last dose (Day 8)
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Part E: The maximum observed plasma concentration (Cmax) of NNC6022 0001 after last dose
Časové okno: From pre-dose (Day 7) until visit 3 (Day 13)
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Measured as µM.
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From pre-dose (Day 7) until visit 3 (Day 13)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Clinical Transparency dept. 2834, Novo Nordisk A/S
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NN6022-8271
- U1111-1333-6460 (Jiný identifikátor: World Health Organization (WHO))
- 2026-525179-26 (Jiný identifikátor: EU CT Number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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