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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01405261
First received: July 27, 2011
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Healthy
Drug: oral NNC 0113-0987
Drug: I.v. NNC 0113-0987
Drug: oral placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Overview of Treatment Emergent Adverse Events (AEs) [ Time Frame: Up to 25 days after trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of hypoglycaemic episodes [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • AUC0-240h; area under the NNC 0113-0987 concentration-time curve [ Time Frame: From time 0 to 240 hours after a single oral or intravenous (i.v.) dose ] [ Designated as safety issue: No ]
  • AUC, area under the curve [ Time Frame: From time 0 to infinity after a single oral or i.v. dose ] [ Designated as safety issue: No ]
  • Cmax; maximum concentration of NNC 0113-0987 in plasma [ Time Frame: After a single oral or i.v. dose ] [ Designated as safety issue: No ]
  • The time to maximum concentration (tmax) of NNC 0113-0987 in plasma [ Time Frame: After a single oral dose ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405261

Locations
United Kingdom
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01405261     History of Changes
Other Study ID Numbers: NN9926-3894, U1111-1119-1560, 2011-000297-57
Study First Received: July 27, 2011
Last Updated: November 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 20, 2014