Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

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

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

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 60 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
  • BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion Criteria:

  • Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
  • Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
  • The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral 1
Drug: semaglutide
Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
Drug: placebo
Placebo (oral) administered once daily for 10 weeks.
Drug: semaglutide
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
Other Names:
  • NN9924
Experimental: Oral 2
Drug: semaglutide
Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
Drug: placebo
Placebo (oral) administered once daily for 10 weeks.
Drug: semaglutide
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
Other Names:
  • NN9924
Experimental: Oral 3
Drug: semaglutide
Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
Drug: placebo
Placebo (oral) administered once daily for 10 weeks.
Drug: semaglutide
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
Other Names:
  • NN9924
Active Comparator: S.c.
Drug: semaglutide
Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
Drug: semaglutide
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
Other Names:
  • NN9924

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of adverse events (AEs)
Time Frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycaemic episodes
Time Frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Laboratory safety variables (haematology, biochemistry, and urinalysis)
Time Frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Maximum plasma concentration of NN9924
Time Frame: after dosing on the 68th, 69th and 70th Day
after dosing on the 68th, 69th and 70th Day
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Time Frame: after dosing on the 68th, 69th and 70th day
after dosing on the 68th, 69th and 70th day
Terminal phase elimination half-life
Time Frame: from last dose (day 70) to follow-up visit 91-105 days after first dose
from last dose (day 70) to follow-up visit 91-105 days after first dose

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, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

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

  • NN9924-3692
  • U1111-1118-0257 (Other Identifier: Who)
  • 2010-019951-23 (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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