This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.
Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.
Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.
Unnamed facility
Nottingham, United Kingdom
Overview of Treatment Emergent Adverse Events (AEs)
Time frame: Up to 25 days after trial product administration
Frequency of hypoglycaemic episodes
Time frame: From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)
AUC0-240h; area under the NNC 0113-0987 concentration-time curve
Time frame: From time 0 to 240 hours after a single oral or intravenous (i.v.) dose
AUC, area under the curve
Time frame: From time 0 to infinity after a single oral or i.v. dose
Cmax; maximum concentration of NNC 0113-0987 in plasma
Time frame: After a single oral or i.v. dose
The time to maximum concentration (tmax) of NNC 0113-0987 in plasma
Time frame: After a single oral dose
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Subjects will be randomised to receive a single dose of placebo.