NCT03617081

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

A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	NNC0113-2023	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.
DRUG	Placebo (NNC0113-2023)	Participants will receive NNC0174-0833 matched placebo orally.

Timeline

• Start date: 2018-08-09
• Primary completion: 2018-12-13
• Completion: 2018-12-13
• First posted: 2018-08-06
• Last updated: 2020-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study