Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.

Official Title
-----------------
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin 338 (GIPET I)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-64 years (both inclusive) at the time of signing informed consent Body mass index 18.5-28.0 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 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 informed consent Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eating meal immediately after dosing<br> | Drug: insulin 338 (GIPET I)<br>* Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.<br>|
| Experimental: Eating meal 30 min after dosing<br> | Drug: insulin 338 (GIPET I)<br>* Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.<br>|
| Experimental: Eating meal 1 hour after dosing<br> | Drug: insulin 338 (GIPET I)<br>* Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.<br>|
| Experimental: Eating meal 6 hour after dosing<br> | Drug: insulin 338 (GIPET I)<br>* Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin 338 concentration-time curve |  | From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin 338 concentration-time curve |  | From 0 to 288 hours after a single dose (SD) | 
| Maximum observed serum insulin 338 concentration |  | From 0 to 288 hours after a single dose (SD) | 
| Area under the plasma capric acid concentration-time curve |  | From 0 to 24 hours after a single dose | 
| Maximum observed plasma capric acid concentration |  | From 0 to 24 hours after a single dose |