A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
Primary Purpose
Healthy Volunteers, High Blood Cholesterol Levels, Type 2 Diabetes
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Semaglutide D
Semaglutide G
Semaglutide H
Semaglutide I
NNC0385-0434 B
NNC0385-0434 C
NNC0385-0434 D
NNC0385-0434 E
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
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).
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: Oral semaglutide
Part B: NNC0385-0434
Arm Description
Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Outcomes
Primary Outcome Measures
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
h * nmol/L
Secondary Outcome Measures
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
nmol/L
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API
hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05129891
Brief Title
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
Official Title
A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
February 26, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, High Blood Cholesterol Levels, Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: Oral semaglutide
Arm Type
Experimental
Arm Description
Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Arm Title
Part B: NNC0385-0434
Arm Type
Experimental
Arm Description
Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Intervention Type
Drug
Intervention Name(s)
Semaglutide D
Intervention Description
Tablet given orally
Intervention Type
Drug
Intervention Name(s)
Semaglutide G
Intervention Description
Tablet given orally
Intervention Type
Drug
Intervention Name(s)
Semaglutide H
Intervention Description
Tablet given orally
Intervention Type
Drug
Intervention Name(s)
Semaglutide I
Intervention Description
Tablet given orally
Intervention Type
Drug
Intervention Name(s)
NNC0385-0434 B
Intervention Description
Tablet given orally
Intervention Type
Drug
Intervention Name(s)
NNC0385-0434 C
Intervention Description
Tablet given orally
Intervention Type
Drug
Intervention Name(s)
NNC0385-0434 D
Intervention Description
Tablet given orally
Intervention Type
Drug
Intervention Name(s)
NNC0385-0434 E
Intervention Description
Tablet given orally
Primary Outcome Measure Information:
Title
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
Description
h * nmol/L
Time Frame
From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
Secondary Outcome Measure Information:
Title
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
Description
nmol/L
Time Frame
From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
Title
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API
Description
hours
Time Frame
From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
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