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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: oral NNC 0113-0987; Drug: oral placebo; Drug: I.v. NNC 0113-0987

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NNC 0113-0987 (gastro)	Drug: oral NNC 0113-0987; Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.; Drug: oral placebo; Subjects will be randomised to receive a single dose of placebo.
EXPERIMENTAL: NNC 0113-987 (coated)	Drug: oral NNC 0113-0987; Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.; Drug: oral placebo; Subjects will be randomised to receive a single dose of placebo.
EXPERIMENTAL: NNC 0113-987 (i.v)	Drug: I.v. NNC 0113-0987; Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overview of Treatment Emergent Adverse Events (AEs)	Up to 25 days after trial product administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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
The time to maximum concentration (tmax) of NNC 0113-0987 in plasma	After a single oral dose

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (ESTIMATE): July 29, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 28, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9926-3894; U1111-1119-1560 (OTHER: WHO); 2011-000297-57 (EUDRACT_NUMBER)