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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129891
• Other study ID #: NN9501-4821
• Secondary ID: U1111-1266-06722
• Status: Completed
• Phase: Phase 1
• Start date: November 3, 2021
• Est. completion date: May 4, 2023

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: May 4, 2023
• Est. primary completion date: February 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteers
• Hypercholesterolemia
• Type 2 Diabetes

Intervention

Drug:
• Semaglutide D
Tablet given orally
• Semaglutide G
Tablet given orally
• Semaglutide H
Tablet given orally
• Semaglutide I
Tablet given orally
• NNC0385-0434 B
Tablet given orally
• NNC0385-0434 C
Tablet given orally
• NNC0385-0434 D
Tablet given orally
• NNC0385-0434 E
Tablet given orally

Locations

Country	Name	City	State
Canada	Altasciences Company Inc.	Montreal	Quebec
Germany	Parexel International GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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