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

February 20, 2015 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses
Other Names:
  • NN9535
Experimental: B
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses
Other Names:
  • NN9535
Experimental: C
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses
Other Names:
  • NN9535

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
a 28 day time period

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax of the plasma NN9535 curve
Time Frame: a 28 day time period
a 28 day time period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-3679
  • 2008-004990-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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