drugset / Trial / NCT05129891

A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

NCT05129891

Phase 1 Completed 384 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

In this study, four new tablet versions of two compounds will be investigated. The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance. Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days. The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)

Timeline

Start
2021-11-03
Primary completion
2023-02-26
Completion
2023-05-04

Drugs

EvaluationDrugModalityDoseRoute
Subject NNC0385-0434 Unknown Oral
Subject Semaglutide Peptide Oral