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

NCT ID: NCT01931137

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

insulin 338 (GIPET I)

Intervention Type: DRUG

Dose level of 8100 nmol will be orally administered as one tablet per dose.

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)

Group Type: EXPERIMENTAL

insulin 338 (GIPET I)

Intervention Type: DRUG

Dose level of 8100 nmol will be orally administered as one tablet per dose.

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)

Group Type: EXPERIMENTAL

insulin 338 (GIPET I)

Intervention Type: DRUG

Dose level of 8100 nmol will be orally administered as one tablet per dose.

Interventions

insulin 338 (GIPET I)

Dose level of 8100 nmol will be orally administered as one tablet per dose.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Neuss, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2012-004202-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1134-6321

Identifier Type: OTHER

Identifier Source: secondary_id

NN1953-3973

Identifier Type: -

Identifier Source: org_study_id