Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Novo Nordisk A/S0 sites101 target enrollmentAugust 2011

ConditionsDiabetes Diabetes Mellitus, Type 2 Healthy

Interventionsoral placebo oral NNC 0113-0987 I.v. NNC 0113-0987

Drugsoral NNC 0113-0987 I.v. NNC 0113-0987 oral placebo

Overview

Phase: Phase 1
Intervention: oral placebo
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 101
Primary Endpoint: Overview of Treatment Emergent Adverse Events (AEs)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

May 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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)

Arms & Interventions

NNC 0113-0987 (gastro)

Intervention: oral placebo

NNC 0113-0987 (gastro)

Intervention: oral NNC 0113-0987

NNC 0113-987 (coated)

Intervention: oral NNC 0113-0987

NNC 0113-987 (coated)

Intervention: oral placebo

NNC 0113-987 (i.v)

Intervention: I.v. NNC 0113-0987

Outcomes

Primary Outcomes

Overview of Treatment Emergent Adverse Events (AEs)

Time Frame: Up to 25 days after trial product administration

Secondary Outcomes

Frequency of hypoglycaemic episodes(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))
The time to maximum concentration (tmax) of NNC 0113-0987 in plasma(After a single oral dose)
AUC0-240h; area under the NNC 0113-0987 concentration-time curve(From time 0 to 240 hours after a single oral or intravenous (i.v.) dose)
AUC, area under the curve(From time 0 to infinity after a single oral or i.v. dose)
Cmax; maximum concentration of NNC 0113-0987 in plasma(After a single oral or i.v. dose)