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

Phase 1

Completed

• Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: I.v. NNC 0113-0987; Drug: oral NNC 0113-0987; Drug: oral placebo

• Registration Number: NCT01405261
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Study Start: 2011-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NNC 0113-987 (i.v)	I.v. NNC 0113-0987	-
NNC 0113-987 (coated)	oral placebo	-
NNC 0113-987 (coated)	oral NNC 0113-0987	-
NNC 0113-0987 (gastro)	oral NNC 0113-0987	-
NNC 0113-0987 (gastro)	oral placebo	-

Primary Outcome Measures

Name	Time	Method
Overview of Treatment Emergent Adverse Events (AEs)	Up to 25 days after trial product administration

Secondary Outcome Measures

Name	Time	Method
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