Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT01515592
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • liraglutide — DRUG
    One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg
  • liraglutide — DRUG
    One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks
  • liraglutide — DRUG
    One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks
  • placebo — DRUG
    Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Study Details

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.

Key Dates

Start date
Jan 31, 2006
Status verified
Jan 2017
Primary completion
Apr 30, 2006
Completion
Apr 30, 2006

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 15 mcg/kg
  • Experimental: 20 mcg/kg
  • Experimental: 25 mcg/kg

Primary Outcome Measure

Adverse events

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