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Completed

NCT Number: NCT02304627

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin 338 (GIPET I)

Drug

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.

Primary outcomes

  1. Area under the serum insulin 338 concentration-time curve

    Time frame: From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points

Secondary outcomes

  1. Area under the serum insulin 338 concentration-time curve

    Time frame: From 0 to 288 hours after a single dose (SD)

  2. Maximum observed serum insulin 338 concentration

    Time frame: From 0 to 288 hours after a single dose (SD)

  3. Area under the plasma capric acid concentration-time curve

    Time frame: From 0 to 24 hours after a single dose

  4. Maximum observed plasma capric acid concentration

    Time frame: From 0 to 24 hours after a single dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2014
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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