A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects
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
2 other identifiers
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started Jan 2009
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFebruary 23, 2015
February 1, 2015
3 months
December 19, 2008
February 20, 2015
Conditions
Outcome Measures
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
a 28 day time period
Secondary Outcomes (1)
Cmax of the plasma NN9535 curve
a 28 day time period
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALInterventions
Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Berlin, 14050, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 22, 2008
Study Start
January 1, 2009
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
February 23, 2015
Record last verified: 2015-02