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Safety and Tolerability of Liraglutide in Healthy Male Volunteers

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01507272
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
9
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Mar 1, 1999
Actual Primary Completion Date :
Dec 1, 1999
Actual Study Completion Date :
Dec 1, 1999

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 Names:
  • 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 Names:
  • 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

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Manchester United Kingdom M15 6SH

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01507272
    Other Study ID Numbers:
    • NN2211-1149
    First Posted:
    Jan 10, 2012
    Last Update Posted:
    Jan 24, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Liraglutide

    Study Results

    No Results Posted as of Jan 24, 2017