Status:
COMPLETED
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 he...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01405261
Start Date
August 1 2011
End Date
May 1 2012
Last Update
November 28 2013
Active Locations (1)
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1
Nottingham, United Kingdom, NG11 6JS