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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01931137

Enrollment

Registered

2013-08-29

Start date

2013-08-31

Completion date

2013-12-31

Last updated

2014-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGinsulin 338 (GIPET I)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Measure	Time frame
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)
Area under the serum insulin 338 concentration-time curve	From 0 to 288 hours after a single dose (SD)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026