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

Sponsor
Novo Nordisk A/S
Study ID
NCT05129891
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide D — DRUG
    Tablet given orally
  • Semaglutide G — DRUG
    Tablet given orally
  • Semaglutide H — DRUG
    Tablet given orally
  • Semaglutide I — DRUG
    Tablet given orally
  • NNC0385-0434 B — DRUG
    Tablet given orally
  • NNC0385-0434 C — DRUG
    Tablet given orally
  • NNC0385-0434 D — DRUG
    Tablet given orally
  • NNC0385-0434 E — DRUG
    Tablet given orally

Study Details

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)

Key Dates

Start date
Nov 3, 2021
Status verified
May 2024
Primary completion
Feb 26, 2023
Completion
May 4, 2023

Study Design

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

Arms

  • Experimental: Part A: Oral semaglutide
    Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
  • Experimental: Part B: NNC0385-0434
    Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days

Primary Outcome Measure

AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose [ Time Frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration ]

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