This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
Unnamed facility
Harrow, United Kingdom
Number of treatment emergent adverse events (TEAEs) recorded
Time frame: From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)
Area under the NNC0113-0987 plasma concentration curve
Time frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
Maximum observed NNC0113-0987 plasma concentration
Time frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
Time to maximum observed NNC0113-0987 plasma concentration
Time frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
Change in fasting plasma glucose (FPG)
Time frame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
Change in HbA1C (glycosylated haemoglobin)
Time frame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
Change in body weight
Time frame: From baseline (Day -1) to after 10 weeks of treatment (Day 70)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.