A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
NCT06097390
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Novo Nordisk A/S
Start date
2023-09-28
Number of sites
- Summary
- In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants.
- Short title
- A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
- Official title
- A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-03-27
- First posted
- 2023-10-24
- Registry last updated
- 2025-07-17
- Primary completion date
- 2024-02-22
- Start date
- 2023-09-28
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06097390
- ClinicalTrials.gov ID
- NCT06097390
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Crossover
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
Timeframe: From 0 to 24 hours after dosing on day 80 and 90
Measured in hour\*nanomoles per liter (h\*nmol/L).
Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration
Timeframe: From 0 to 24 hours after dosing on day 80 and 90
Measured in nanomoles per liter (nmol/L).
Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration
Timeframe: From 0 to 24 hours after dosing on day 80 and 90
Measured in hours.
t½,sema; the terminal half-life of semaglutide
Timeframe: From 0 to 840 hours after dosing on day 90
Measured in hours.
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 64 Years
- Healthy volunteers
- Yes
Key inclusion criteria:
- Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.
- 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.
Key exclusion criteria:
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.
Sources for eligibility
- Altasciences Clinical Company, IncMontreal, Canada
Sources for sites
Other registry identifiers
- U1111-1289-1040
Sources for references