Back to resultsInvestigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Healthy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
semaglutide
placebo
semaglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Oral 1
Oral 2
Oral 3
S.c.
Arm Description
Outcomes
Primary Outcome Measures
Frequency of adverse events (AEs)
Secondary Outcome Measures
Hypoglycaemic episodes
Laboratory safety variables (haematology, biochemistry, and urinalysis)
Maximum plasma concentration of NN9924
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Terminal phase elimination half-life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01272973
Brief Title
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
Official Title
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral 1
Arm Type
Experimental
Arm Title
Oral 2
Arm Type
Experimental
Arm Title
Oral 3
Arm Type
Experimental
Arm Title
S.c.
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo (oral) administered once daily for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
semaglutide
Other Intervention Name(s)
NN9924
Intervention Description
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Maximum plasma concentration of NN9924
Time Frame
after dosing on the 68th, 69th and 70th Day
Title
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Time Frame
after dosing on the 68th, 69th and 70th day
Title
Terminal phase elimination half-life
Time Frame
from last dose (day 70) to follow-up visit 91-105 days after first dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
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