Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Healthy
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
oral NNC 0113-0987
oral NNC 0113-0987
I.v. NNC 0113-0987
oral placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments at the screening visit
- Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m^2
Exclusion Criteria:
- Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
- The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial
- Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the investigator
- Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
- History of chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
NNC 0113-0987 (gastro)
NNC 0113-987 (coated)
NNC 0113-987 (i.v)
Arm Description
Outcomes
Primary Outcome Measures
Overview of Treatment Emergent Adverse Events (AEs)
Secondary Outcome Measures
Frequency of hypoglycaemic episodes
AUC0-240h; area under the NNC 0113-0987 concentration-time curve
AUC, area under the curve
Cmax; maximum concentration of NNC 0113-0987 in plasma
The time to maximum concentration (tmax) of NNC 0113-0987 in plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01405261
Brief Title
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
Official Title
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (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 this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 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
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC 0113-0987 (gastro)
Arm Type
Experimental
Arm Title
NNC 0113-987 (coated)
Arm Type
Experimental
Arm Title
NNC 0113-987 (i.v)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oral NNC 0113-0987
Intervention Description
Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.
Intervention Type
Drug
Intervention Name(s)
oral NNC 0113-0987
Intervention Description
Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.
Intervention Type
Drug
Intervention Name(s)
I.v. NNC 0113-0987
Intervention Description
Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.
Intervention Type
Drug
Intervention Name(s)
oral placebo
Intervention Description
Subjects will be randomised to receive a single dose of placebo.
Primary Outcome Measure Information:
Title
Overview of Treatment Emergent Adverse Events (AEs)
Time Frame
Up to 25 days after trial product administration
Secondary Outcome Measure Information:
Title
Frequency of hypoglycaemic episodes
Time Frame
From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)
Title
AUC0-240h; area under the NNC 0113-0987 concentration-time curve
Time Frame
From time 0 to 240 hours after a single oral or intravenous (i.v.) dose
Title
AUC, area under the curve
Time Frame
From time 0 to infinity after a single oral or i.v. dose
Title
Cmax; maximum concentration of NNC 0113-0987 in plasma
Time Frame
After a single oral or i.v. dose
Title
The time to maximum concentration (tmax) of NNC 0113-0987 in plasma
Time Frame
After a single oral dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments at the screening visit
Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m^2
Exclusion Criteria:
Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial
Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the investigator
Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
History of chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)
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
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
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