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Safety and Tolerability of Liraglutide in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01507272
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: liraglutide Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 1999
Primary Completion Date : December 1999
Study Completion Date : December 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: NNC 90-1170 (liraglutide) Drug: liraglutide
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
Other Name: NNC 90-1170
Drug: liraglutide
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
Other Name: NNC 90-1170
Placebo Comparator: Placebo 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

Outcome Measures

Primary Outcome Measures :
  1. AUC (area under the curve)

Secondary Outcome Measures :
  1. Cmax, maximum concentration
  2. tmax, time to maximum concentration
  3. t½, terminal half-life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507272

United Kingdom
Novo Nordisk Investigational Site
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507272     History of Changes
Other Study ID Numbers: NN2211-1149
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists