| Trial ID: | L4008 |
| Source ID: | NCT03617081
|
| Associated Drug: |
Nnc0113-2023
|
| Title: |
First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: NNC0113-2023|DRUG: Placebo (NNC0113-2023)
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events (TEAEs), Count of events, From time of dosing (day 1) until completion of the follow-up visit (day 43) | Secondary: AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023, Measured in nmol/L\*h, From baseline (day 1) to post treatment follow-up (day 43)|Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023, Measured in nmol/L, From baseline (day 1) to post treatment follow-up (day 43)|AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023, Measured in ng/mL\*h, From baseline (day 1) to 24 hours after dosing|Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023, Measured in ng/mL, From baseline (day 1) to 24 hours after dosing
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-08-09
|
| Completion Date: |
2018-12-13
|
| Results First Posted: |
|
| Last Update Posted: |
2020-01-10
|
| Locations: |
Novo Nordisk Investigational Site, San Antonio, Texas, 78209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03617081
|
