A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets

Sponsor
Novo Nordisk A/S
Study ID
NCT04097600
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Oral semaglutide — DRUG
    Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks

Study Details

In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. One is the current formulation and the other one is a new formulation of semaglutide. Both will be administered as a tablet and are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. The tablet version of the study medicine is a new medicine that cannot yet be prescribed. Participants will either get semaglutide in the current tablet formulation previously tested in many large studies, or get the tablet that contains semaglutide in a new formulation - which treatment is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment in a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.

Key Dates

Start date
Sep 30, 2019
Status verified
Sep 2022
Primary completion
Dec 16, 2020
Completion
Jan 20, 2021

Study Design

Enrollment
274 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1
    Current form 3 mg in treatment period 1, followed by current form 7 mg in treatment period 2, followed by new form 11.2 mg in treatment period 3
  • Experimental: Sequence 2
    Current form 3 mg in treatment period 1, followed by new form 5.6 mg in treatment period 2, followed by current form 14 mg in treatment period 3
  • Experimental: Sequence 3
    New form 2.4 mg in treatment period 1, followed by current form 7 mg in treatment period 2, followed by current form 14 mg in treatment period 3
  • Experimental: Sequence 4
    New form 2.4 mg in treatment period 1, followed by new form 5.6 mg in treatment period 2, followed by current form 14 mg in treatment period 3
  • Experimental: Sequence 5
    New form 2.4 mg in treatment period 1, followed by current form 7 mg in treatment period 2, followed by new form 11.2 mg in treatment period 3
  • Experimental: Sequence 6
    Current form 3 mg in treatment period 1, followed by new form 5.6 mg in treatment period 2, followed by new form 11.2 mg in treatment period 3

Primary Outcome Measure

AUC0-24h,sema,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state [ Time Frame: From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively ]

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