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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304627
• Other study ID #: NN1953-3974
• Secondary ID: 2014-000979-87U1
• Status: Completed
• Phase: Phase 1
• Start date: November 24, 2014
• Est. completion date: July 31, 2015

Study information

• Verified date: July 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 31, 2015
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Halberg IB, Lyby K, Wassermann K, Heise T, Plum-Mörschel 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 May 16. doi: 10.1007/s40262-01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Area under the serum insulin 338 concentration-time curve		From 0 to 288 hours after a single dose (SD)
Secondary	Maximum observed serum insulin 338 concentration		From 0 to 288 hours after a single dose (SD)
Secondary	Area under the plasma capric acid concentration-time curve		From 0 to 24 hours after a single dose
Secondary	Maximum observed plasma capric acid concentration		From 0 to 24 hours after a single dose

External Links

•   Clinical Trials at Novo Nordisk