This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.
Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts.
In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.
Unnamed facility
Berlin, Germany
Part A: Number of treatment emergent adverse events (TEAEs)
Time frame: Day -1 to Day 24
Part B: Number of treatment emergent adverse events (TEAEs)
Time frame: Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104)
Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve
Time frame: From time 0 to 24 hours after a single dose (Day 0)
Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve
Time frame: Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)
Part B: Change in fasting plasma glucose (FPG) from baseline
Time frame: Day 0 (pre-dose), day 70
Part B: Change in body weight from baseline
Time frame: Day -1, day 70
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C).