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Completed

NCT Number: NCT01931137

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

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.

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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–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

insulin 338 (GIPET I)

Drug

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

Primary outcomes

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

    Time frame: From dosing to infinity calculated from a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 38 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. Area under the glucose infusion rate (GIR)-time curve

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

  3. Number of treatment emergent adverse events

    Time frame: As recorded from trial product administration (Day 1) at Sub-visit A and until Sub-visit G (Day 13)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2013
Registry last updated
Jan 6, 2014

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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