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

NCT05129891 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2024-05-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Canada
  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129891 on ClinicalTrials.gov