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

Phase 1

Completed

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

• Registration Number: NCT02304627
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-21
• Study Start: 2014-11-24
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-12-02
• Primary Completion: 2015-07-31
• Study Completion: 2015-07-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eating meal immediately after dosing	insulin 338 (GIPET I)	-
Eating meal 30 min after dosing	insulin 338 (GIPET I)	-
Eating meal 1 hour after dosing	insulin 338 (GIPET I)	-
Eating meal 6 hour after dosing	insulin 338 (GIPET I)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany