Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Healthy; Diabetes
• Interventions: Drug: NNC0113-0987; Drug: placebo

• Registration Number: NCT01690169
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-07
• Study Start: 2012-09-14
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Primary Completion: 2012-12-11
• Study Completion: 2012-12-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0113-0987	NNC0113-0987	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

Secondary Outcome Measures

Name	Time	Method
Cmax, the maximum plasma concentration of NNC0113-0987	From dosing visit until last PK sampling visit (e.g. day 11)
AUC, the area under the NNC0113-0987 plasma concentration-time curve	From dosing visit to infinity
Number and severity of hypoglycaemic episodes	From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
tmax, the time to maximum plasma concentration of NNC0113-0987	From dosing visit until last PK sampling visit (e.g. day 11)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Nottingham, United Kingdom