Novo Nordisk Investigational Site
San Antonio, Texas, 78209, United States
NCT Number: NCT03617081
The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
San Antonio, Texas, 78209, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.
Participants will receive NNC0174-0833 matched placebo orally.
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 43)
Count of events
Time frame: From baseline (day 1) to post treatment follow-up (day 43)
Measured in nmol/L*h
Time frame: From baseline (day 1) to post treatment follow-up (day 43)
Measured in nmol/L
Time frame: From baseline (day 1) to 24 hours after dosing
Measured in ng/mL*h
Time frame: From baseline (day 1) to 24 hours after dosing
Measured in ng/mL
Novo Nordisk A/S
Industry
A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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