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Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

NCT03638778 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-11-14

No results posted yet for this study

Summary

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Semaglutide 3 mg

Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.

DRUG

Semaglutide 7 mg

Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.

DRUG

Semaglutide B 3 mg

Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.

DRUG

Semaglutide B 7 mg

Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.

DRUG

Semaglutide C 3 mg

Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.

DRUG

Semaglutide C 7 mg

Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.

DRUG

Semaglutide D 3 mg

Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.

DRUG

Semaglutide D 7 mg

Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2018-12-05
Completion
2018-12-05
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT03638778 on ClinicalTrials.gov