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Completed

NCT Number: NCT05129891

A Research Study Looking at New Protein-based Tablets 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)

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Company Inc., Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Semaglutide D

Drug

Tablet given orally

Semaglutide G

Drug

Tablet given orally

Semaglutide H

Drug

Tablet given orally

Semaglutide I

Drug

Tablet given orally

NNC0385-0434 B

Drug

Tablet given orally

NNC0385-0434 C

Drug

Tablet given orally

NNC0385-0434 D

Drug

Tablet given orally

NNC0385-0434 E

Drug

Tablet given orally

Primary outcomes

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

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

    h * nmol/L

Secondary outcomes

  1. Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose

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

    nmol/L

  2. tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API

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

    hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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