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A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV
A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
90
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 22-31.9•Male•Healthy volunteers
Primary endpoints
•Adjusted AUC(sema)•Adjusted Cmax,(sema)•Adjusted tmax,sema
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male.
2. Age 18-64 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
4. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
1. Known or suspected hypersensitivity to study interventions or related products.
2. Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. 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 prior to first dosing.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
4 endpointsAdjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve
Time frame:From 0 to 24 hours after dosing on Days 122 and 132.
AUC₀–∞
concentration, descriptive
Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration
Time frame:From 0 to 24 hours after dosing on Days 122 and 132.
Cmax
concentration, descriptive
Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration
Time frame:From 0 to 24 hours after dosing on Days 122 and 132.
Tmax
descriptive
t½,sema; the terminal half-life of semaglutide
Time frame:From 0 to 840 hours after dosing on Day 132.
Half-life
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.