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

Sponsor
Novo Nordisk A/S
Study ID
NCT03638778
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide 3 mg — DRUG
    Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.
  • Semaglutide 7 mg — DRUG
    Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.
  • Semaglutide B 3 mg — DRUG
    Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.
  • Semaglutide B 7 mg — DRUG
    Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.
  • Semaglutide C 3 mg — DRUG
    Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.
  • Semaglutide C 7 mg — DRUG
    Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.
  • Semaglutide D 3 mg — DRUG
    Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.
  • Semaglutide D 7 mg — DRUG
    Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

Study Details

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.

Key Dates

Start date
Aug 17, 2018
Status verified
Nov 2019
Primary completion
Dec 5, 2018
Completion
Dec 5, 2018

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oral semaglutide (reference)
    Participants will receive oral semaglutide (reference) for 10 days.
  • Experimental: Oral semaglutide formulation B
    Participants will receive oral semaglutide formulation B for 10 days.
  • Experimental: Oral semaglutide formulation C
    Participants will receive oral semaglutide formulation C for 10 days.
  • Experimental: Oral semaglutide formulation D
    Participants will receive oral semaglutide formulation D for 10 days.

Primary Outcome Measure

AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing [ Time Frame: 0 to 24 hours on day 10 ]

Related Studies