Safety and Tolerability of Liraglutide in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507272
First received: January 5, 2012
Last updated: April 25, 2014
Last verified: April 2014

January 5, 2012
April 25, 2014
March 1999
December 1999   (final data collection date for primary outcome measure)
AUC (area under the curve) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01507272 on ClinicalTrials.gov Archive Site
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • tmax, time to maximum concentration [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Liraglutide in Healthy Male Volunteers
A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Healthy
  • Drug: NNC 90-1170
    Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
  • Drug: NNC 90-1170
    Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg
  • Drug: placebo
    Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
  • Drug: placebo
    Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
  • Experimental: NNC 90-1170 (liraglutide)
    Interventions:
    • Drug: NNC 90-1170
    • Drug: NNC 90-1170
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: placebo
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
December 1999
December 1999   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male subjects of any ethnic origin
  • Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
  • Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
  • Body mass index within the range 20-27 kg/m^2, inclusive

Exclusion Criteria:

  • Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
  • History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
  • Alcohol intake within 48 hours of visit
  • Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
  • History of significant drug allergy or drug hypersensitivity
  • Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
  • Subjects who drink more than 8 cups of tea/coffee per day
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01507272
NN2211-1149
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP