Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.
Interventions
DRUGNN9925 (oral)
Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation
DRUGNN9925 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
DRUGplacebo
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male subjects with good general health as judged by the physician * Body weight of 65-95 kg (both inclusive) * Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)
Exclusion criteria
* Known or suspected allergy to trial product or related products * Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and severity of adverse events (AEs) recorded | from dosing to Day 22 |
Secondary
| Measure | Time frame |
|---|---|
| The uptake in blood of oral NN9925 | from 0 to 504 hours |
Countries
United Kingdom
Outcome results
None listed