A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

Study Overview
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Brief Summary
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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 NN9924 in healthy male subjects.

Official Title
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Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects

Conditions
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Diabetes, Diabetes Mellitus, Type 2, Healthy

Intervention / Treatment
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* Drug: NN9924 (oral)
* Drug: placebo
* Drug: NN9924 (oral)
* Drug: placebo
* Drug: NN9924 (s.c.)
* Drug: NN9924 (i.v.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects with good general health as judged by the Investigator Body weight of 65.0-95.0 kg (both inclusive) Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (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 Investigator Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial part 1<br> | Drug: NN9924 (oral)<br>* Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation.<br>Drug: placebo<br>* Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.<br>|
| Experimental: Trial part 2<br> | Drug: NN9924 (oral)<br>* Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.<br>Drug: placebo<br>* Subjects will be randomized to receive a single dose of placebo.<br>Drug: NN9924 (s.c.)<br>* As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit<br>Drug: NN9924 (i.v.)<br>* As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of adverse events (AEs) recorded |  | from dosing to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound |  | from 0 to 504 hours |