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Clinical Trial Details

Trial ID: L5622
Source ID: NCT06685185
Associated Drug: Nnc0363-1063
Title: A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: NNC0363-1063|DRUG: Placebo|DRUG: Insulin degludec
Outcome Measures: Primary: Part 1 SAD: Number of adverse events, Measured in number of events., From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)|Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose, Measured in millilitre per hour\*kilogram (mL/\[h\*kg\])., From IMP administration at day 1 up to 7 days|Part 3 MAD: Number of adverse events, Measured in number of events., From IMP administration at day 1 until day of the end of study visit at day 15 | Secondary: Part 1 SAD: Number of hypoglycaemic episodes, Measured in number of episodes., From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)|Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose, Measured in hours\*picomoles per litre(h\*pmol/L)., Up to 7 days|Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose, Measured in h\*pmol/L., Up to 2 days|Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose, Measured in picomoles per litre (pmol/L)., Up to 7 days|Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose, Measured in h\*pmol/L., Up to 7 days|Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose, Measured in h\*pmol/L., Up to 2 days|Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose, Measured in pmol/L., Up to 7 days|Part 3 MAD: Number of hypoglycaemic episodes, Measured in number of episodes., From IMP administration (day 1) until day of the end of study visit (day 15)|Part 3 MAD: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state, Measured in h\*pmol/L., At day 5 and 8|Part 3 MAD: Cmax,I1063,SS- Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state, Measured in pmol/L., At day 5 and 8
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 154
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-12
Completion Date: 2025-07-24
Results First Posted:
Last Update Posted: 2024-11-19
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT06685185