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

NCT03638778 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN9924-4427U1111-1206-62102017-005023-24
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing

  Calculated based on semaglutide measured in blood.

  0 to 24 hours on day 10

Secondary Outcomes (5)

• Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

  0 to 24 hours on day 10

• tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

  0 to 24 hours on day 10

• AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing

  0 to 30 minutes on day 10

• t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing

  Days 10-45

• Number of treatment emergent adverse events

  Days 1-47

Study Arms (4)

Oral semaglutide (reference)

ACTIVE COMPARATOR

Participants will receive oral semaglutide (reference) for 10 days.

Drug: Semaglutide 3 mg; Drug: Semaglutide 7 mg

Oral semaglutide formulation B

EXPERIMENTAL

Participants will receive oral semaglutide formulation B for 10 days.

Drug: Semaglutide B 3 mg; Drug: Semaglutide B 7 mg

Oral semaglutide formulation C

EXPERIMENTAL

Participants will receive oral semaglutide formulation C for 10 days.

Drug: Semaglutide C 3 mg; Drug: Semaglutide C 7 mg

Oral semaglutide formulation D

EXPERIMENTAL

Participants will receive oral semaglutide formulation D for 10 days.

Drug: Semaglutide D 3 mg; Drug: Semaglutide D 7 mg

Interventions

Semaglutide 3 mg DRUG

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

Oral semaglutide (reference)

Semaglutide 7 mg DRUG

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

Oral semaglutide (reference)

Semaglutide B 3 mg DRUG

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

Oral semaglutide formulation B

Semaglutide B 7 mg DRUG

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

Oral semaglutide formulation B

Semaglutide C 3 mg DRUG

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

Oral semaglutide formulation C

Semaglutide C 7 mg DRUG

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

Oral semaglutide formulation C

Semaglutide D 3 mg DRUG

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

Oral semaglutide formulation D

Semaglutide D 7 mg DRUG

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

Oral semaglutide formulation D

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 20, 2018
• Study Start: August 17, 2018
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)