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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Drug: insulin 338 (GIPET I)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Coating A; 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); Dose level of 8100 nmol will be orally administered as one tablet per dose.
EXPERIMENTAL: Coating B; 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); Dose level of 8100 nmol will be orally administered as one tablet per dose.
EXPERIMENTAL: Coating C; 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); Dose level of 8100 nmol will be orally administered as one tablet per dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (ESTIMATE): August 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: NN1953-3973; 2012-004202-10 (EUDRACT_NUMBER); U1111-1134-6321 (OTHER: WHO)