Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT01620463
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
20 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • liraglutide — DRUG
    Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
  • placebo — DRUG
    Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group

Study Details

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.

Key Dates

Start date
Dec 31, 2002
Status verified
Jan 2017
Primary completion
Mar 31, 2003
Completion
Mar 31, 2003

Study Design

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

Arms

  • Experimental: NNC 90-1170
  • Placebo Comparator: Placebo

Primary Outcome Measure

Body weight

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