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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Novo Nordisk
- Numero di telefono: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Luoghi di studio
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Groningen, Olanda, 9728 NZ
- ICON - location Groningen
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Clinical Transparency dept. 2834, Novo Nordisk A/S
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NN6022-8271
- U1111-1333-6460 (Altro identificatore: World Health Organization (WHO))
- 2026-525179-26 (Altro identificatore: EU CT Number)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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