Safety and Tolerability of Liraglutide in Healthy Male Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT01507272
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    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
  • liraglutide — DRUG
    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
  • placebo — DRUG
    Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
  • placebo — DRUG
    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

Study Details

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).

Key Dates

Start date
Mar 31, 1999
Status verified
Jan 2017
Primary completion
Dec 31, 1999
Completion
Dec 31, 1999

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC 90-1170 (liraglutide)
  • Placebo Comparator: Placebo

Primary Outcome Measure

AUC (area under the curve)

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