Overview

Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
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)