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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405261
• Other study ID #: NN9926-3894
• Secondary ID: U1111-1119-15602
• Status: Completed
• Phase: Phase 1
• First received: July 27, 2011
• Last updated: November 27, 2013
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

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.
• 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.
• 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.
• oral placebo
Subjects will be randomised to receive a single dose of placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overview of Treatment Emergent Adverse Events (AEs)		Up to 25 days after trial product administration	No
Secondary	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)	No
Secondary	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	No
Secondary	AUC, area under the curve		From time 0 to infinity after a single oral or i.v. dose	No
Secondary	Cmax; maximum concentration of NNC 0113-0987 in plasma		After a single oral or i.v. dose	No
Secondary	The time to maximum concentration (tmax) of NNC 0113-0987 in plasma		After a single oral dose	No

External Links

•   Clinical Trials at Novo Nordisk