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

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.

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
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eating meal immediately after dosing	Drug: insulin 338 (GIPET I); 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.
Experimental: Eating meal 30 min after dosing	Drug: insulin 338 (GIPET I); 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.
Experimental: Eating meal 1 hour after dosing	Drug: insulin 338 (GIPET I); 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.
Experimental: Eating meal 6 hour after dosing	Drug: insulin 338 (GIPET I); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Halberg IB, Lyby K, Wassermann K, Heise T, Plum-Morschel L, Zijlstra E. The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects. Clin Pharmacokinet. 2019 Nov;58(11):1497-1504. doi: 10.1007/s40262-019-00772-2.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2014
• Primary Completion (Actual): July 31, 2015
• Study Completion (Actual): July 31, 2015

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: NN1953-3974; 2014-000979-87 (EudraCT Number); U1111-1154-0535 (Other Identifier: WHO)