Berlin, 14050, Germany
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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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugComparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
Primary outcomes
-
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
-
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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