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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin 338 (GIPET I)

• Registration Number: NCT01931137
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coating A	insulin 338 (GIPET I)	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)
Coating B	insulin 338 (GIPET I)	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)
Coating C	insulin 338 (GIPET I)	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)