A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy 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, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers. The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.

Official Title
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A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

Conditions
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Diabetes, Diabetes Mellitus, Type 2, Healthy

Intervention / Treatment
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* Drug: NNC 0148-0000-0362
* Drug: insulin glargine
* Drug: placebo
* Drug: NNC 0148-0000-0362
* Drug: NNC 0148-0000-0362
* Drug: NNC 0148-0000-0362


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index 18-28 kg/m^2 (both inclusive) Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator Exclusion Criteria: Known or suspected hypersensitivity to trial products or related products Previous participation in this trial. Participation is defined as randomised Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Part 1, level 1-7 escalating doses<br> | Drug: NNC 0148-0000-0362<br>* Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group<br>Drug: insulin glargine<br>* As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group<br>Drug: placebo<br>* Subjects will receive a single dose of oral placebo within each dose group<br>|
| Experimental: Part 2, cross-over<br> | Drug: NNC 0148-0000-0362<br>* Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period<br>Drug: NNC 0148-0000-0362<br>* Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period<br>Drug: NNC 0148-0000-0362<br>* Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve (with Trial part 1) |  | From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively | 
| Area under the glucose infusion rate (GIR)-time curve (Trial part 1) |  | From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively | 
| Area under the serum insulin concentration-time curve (Trial part 2) |  | From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively |