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

NCT05129891 | Completed Phase 1

• 3 other identifiers: NN9501-4821U1111-1266-06722021-001452-34
• Study Type: interventional
• Target: 384
• Locations: 2 countries
• Sites: 2

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)

Conditions

Healthy Volunteers; High Blood Cholesterol Levels; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose

  h \* nmol/L

  From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Part A: Oral semaglutide

EXPERIMENTAL

Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days

Drug: Semaglutide D; Drug: Semaglutide G; Drug: Semaglutide H; Drug: Semaglutide I

Part B: NNC0385-0434

EXPERIMENTAL

Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days

Drug: NNC0385-0434 B; Drug: NNC0385-0434 C; Drug: NNC0385-0434 D; Drug: NNC0385-0434 E

Interventions

Semaglutide D DRUG

Tablet given orally

Part A: Oral semaglutide

Semaglutide G DRUG

Tablet given orally

Part A: Oral semaglutide

Semaglutide H DRUG

Tablet given orally

Part A: Oral semaglutide

Semaglutide I DRUG

Tablet given orally

Part A: Oral semaglutide

NNC0385-0434 B DRUG

Tablet given orally

Part B: NNC0385-0434

NNC0385-0434 C DRUG

Tablet given orally

Part B: NNC0385-0434

NNC0385-0434 D DRUG

Tablet given orally

Part B: NNC0385-0434

NNC0385-0434 E DRUG

Tablet given orally

Part B: NNC0385-0434

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Altasciences Company Inc.

Montreal, Quebec, H3P 3P1, Canada

Location

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: November 22, 2021
• Study Start: November 3, 2021
• Primary Completion: February 26, 2023
• Study Completion: May 4, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); CA (1)