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

A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants

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)

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 384
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3P 3P1
      • Altasciences Company Inc.
• Germany
  • Berlin, Germany, 14050
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Semaglutide D; Tablet given orally; Drug: Semaglutide G; Tablet given orally; Drug: Semaglutide H; Tablet given orally; Drug: Semaglutide I; Tablet given orally
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	Drug: NNC0385-0434 B; Tablet given orally; Drug: NNC0385-0434 C; Tablet given orally; Drug: NNC0385-0434 D; Tablet given orally; Drug: NNC0385-0434 E; Tablet given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose	nmol/L	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	hours	From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): February 26, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN9501-4821; U1111-1266-0672 (Other Identifier: World Health Organization (WHO)); 2021-001452-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No