Clinical trial NCT01405261: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 101
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Overview of Treatment Emergent Adverse Events (AEs)
timeFrame: Up to 25 days after trial product administration
Secondary outcomes:
measure: Frequency of hypoglycaemic episodes
timeFrame: 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)
measure: AUC0-240h; area under the NNC 0113-0987 concentration-time curve
timeFrame: From time 0 to 240 hours after a single oral or intravenous (i.v.) dose
measure: AUC, area under the curve
timeFrame: From time 0 to infinity after a single oral or i.v. dose
measure: Cmax; maximum concentration of NNC 0113-0987 in plasma
timeFrame: After a single oral or i.v. dose
measure: The time to maximum concentration (tmax) of NNC 0113-0987 in plasma
timeFrame: After a single oral dose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: