A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet formulation with three different coatings in healthy subjects.

Official Title
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A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects

Conditions
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Diabetes, Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index 18.0-28.0 kg/m^2 (both inclusive) Subject who is considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG (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 gastro-intestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coating A<br>Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) | Drug: insulin 338 (GIPET I)<br>* Dose level of 8100 nmol will be orally administered as one tablet per dose.<br>|
| Experimental: Coating B<br>Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) | Drug: insulin 338 (GIPET I)<br>* Dose level of 8100 nmol will be orally administered as one tablet per dose.<br>|
| Experimental: Coating C<br>Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) | Drug: insulin 338 (GIPET I)<br>* Dose level of 8100 nmol will be orally administered as one tablet per dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin 338 concentration-time curve |  | From dosing to infinity calculated from a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 38 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) | 
| Area under the glucose infusion rate (GIR)-time curve |  | From 0 to 24 hours after a single dose | 
| Number of treatment emergent adverse events |  | As recorded from trial product administration (Day 1) at Sub-visit A and until Sub-visit G (Day 13) |