Clinical trial NCT01690169: Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects
Official title: Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 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: 2012-09-21
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 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 assessments at the screening visit
* Body mass index (BMI) above or equal to 18.5 and below 30 kg/m\^ 2

Exclusion Criteria:

* Male subjects who are sexually active and not surgically sterilised, who or whose partner is 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 12 weeks following the last dose of trial medication
* Participation in another trial within 90 days prior to screening
* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an 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 acute idiopathic or chronic pancreatitis

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
Secondary outcomes:
measure: Number and severity of hypoglycaemic episodes
timeFrame: From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
measure: AUC, the area under the NNC0113-0987 plasma concentration-time curve
timeFrame: From dosing visit to infinity
measure: Cmax, the maximum plasma concentration of NNC0113-0987
timeFrame: From dosing visit until last PK sampling visit (e.g. day 11)
measure: tmax, the time to maximum plasma concentration of NNC0113-0987
timeFrame: From dosing visit until last PK sampling visit (e.g. day 11)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References: