- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studiesteder
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Groningen, Holland, 9728 NZ
- ICON - location Groningen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Placebo komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Clinical Transparency dept. 2834, Novo Nordisk A/S
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
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
- NN6022-8271
- U1111-1333-6460 (Anden identifikator: World Health Organization (WHO))
- 2026-525179-26 (Anden identifikator: EU CT Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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