drugset / Trial / NCT03617081

First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.

NCT03617081 ↗

Phase 1 Completed 40 enrolled Novo Nordisk A/S
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2018-08-09
Primary completion
2018-12-13
Completion
2018-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject NNC0113-2023 Unknown 1 mg Oral
Subject NNC0113-2023 Unknown 2 mg Oral
Subject NNC0113-2023 Unknown 4 mg Oral
Subject NNC0113-2023 Unknown 8 mg Oral
Subject NNC0113-2023 Unknown 16 mg Oral
Subject NNC0113-2023 Unknown 32 mg Oral