NCT05129891

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

A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Conditions

• Healthy Volunteers
• High Blood Cholesterol Levels
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Semaglutide D	Tablet given orally
DRUG	Semaglutide G	Tablet given orally
DRUG	Semaglutide H	Tablet given orally
DRUG	Semaglutide I	Tablet given orally
DRUG	NNC0385-0434 B	Tablet given orally
DRUG	NNC0385-0434 C	Tablet given orally
DRUG	NNC0385-0434 D	Tablet given orally
DRUG	NNC0385-0434 E	Tablet given orally

Timeline

• Start date: 2021-11-03
• Primary completion: 2023-02-26
• Completion: 2023-05-04
• First posted: 2021-11-22
• Last updated: 2024-05-29

Locations

2 sites across 2 countries: Canada, Germany