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Completed

NCT Number: NCT00813020

A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator
  • Body weight between 80 kg and 110 kg (both inclusive)
  • Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive
  • Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)

Exclusion criteria

  • Known or suspected allergy to trial product(s) or related products
  • Previous participation in this trial (randomisation)
  • The receipt of any investigational medicinal product within 3 months prior to this trial
  • Subjects who have had a clinically relevant illness within 4 weeks of dosing
  • History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
  • Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period

Treatment and study plan

semaglutide

Drug

Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses

Primary outcomes

  1. AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration

    Time frame: a 28 day time period

Secondary outcomes

  1. Cmax of the plasma NN9535 curve

    Time frame: a 28 day time period

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Single Centre, Double-blind, Incomplete Block Trial to Test for Equivalence Between Subcutaneous Injections of the GLP-1 Analogue NN9535 in 1 mg/ml, 3 mg/ml and 10 mg/ml Concentrations in Healthy Male Subject

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Feb 23, 2015

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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