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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05129891
Collaborator
(none)
384
Enrollment
1
Location
2
Arms
12.3
Anticipated Duration (Months)
31.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • 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
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants
Actual Study Start Date :
Nov 3, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 11, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Berlin Germany 14050

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT05129891
Other Study ID Numbers:
  • NN9501-4821
  • U1111-1266-0672
  • 2021-001452-34
First Posted:
Nov 22, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypercholesterolemia

Study Results

No Results Posted as of Nov 22, 2021