Part A: Oral semaglutide for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy Subjects+2 MoreSemaglutide D - Drug
Eligibility
18 - 55
Male
What conditions do you have?
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Study Summary

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)

Eligible Conditions
  • Healthy Subjects
  • High Cholesterol
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration

Day 10
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Part A: Oral semaglutide
1 of 2
Part B: NNC0385-0434
1 of 2

Experimental Treatment

384 Total Participants · 2 Treatment Groups

Primary Treatment: Part A: Oral semaglutide · No Placebo Group · Phase 1

Part A: Oral semaglutideExperimental Group · 4 Interventions: Semaglutide D, Semaglutide H, Semaglutide I, Semaglutide G · Intervention Types: Drug, Drug, Drug, Drug
Part B: NNC0385-0434Experimental Group · 4 Interventions: NNC0385-0434 C, NNC0385-0434 D, NNC0385-0434 B, NNC0385-0434 E · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0385-0434 B
2022
Completed Phase 1
~160

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from pre-dose pk sample (0 hours) at day 10 to pk sample 24 hours after dose administration

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,405 Previous Clinical Trials
2,308,655 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
53,488 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · Male Participants · 4 Total Inclusion Criteria

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