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

Phase 1

Completed

• Conditions: Healthy Volunteers; High Blood Cholesterol Levels; Type 2 Diabetes
• Interventions: Drug: Semaglutide D; Drug: NNC0385-0434 B; Drug: Semaglutide G; Drug: NNC0385-0434 C; Drug: Semaglutide H; Drug: NNC0385-0434 D; Drug: NNC0385-0434 E; Drug: Semaglutide I

• Registration Number: NCT05129891
• Lead Sponsor: Novo Nordisk A/S

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-09
• Study Start: 2021-11-03
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-22
• Primary Completion: 2023-02-26
• Study Completion: 2023-05-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 384

Inclusion Criteria

• Male.
• Aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria

• Known or suspected hypersensitivity to study interventions or related products.
• Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.
• Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
• History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Oral semaglutide	Semaglutide G	Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part A: Oral semaglutide	Semaglutide H	Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part B: NNC0385-0434	NNC0385-0434 C	Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part B: NNC0385-0434	NNC0385-0434 E	Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part A: Oral semaglutide	Semaglutide D	Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part A: Oral semaglutide	Semaglutide I	Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part B: NNC0385-0434	NNC0385-0434 B	Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part B: NNC0385-0434	NNC0385-0434 D	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 Measures

Name	Time	Method
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose	From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration	h \* nmol/L

Secondary Outcome Measures

Name	Time	Method
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose	From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration	nmol/L
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API	From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration	hours

Trial Locations

Locations (2)

Parexel International GmbH; 🇩🇪 Berlin, Germany

Altasciences Company Inc.; 🇨🇦 Montreal, Quebec, Canada