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Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

NCT01620476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-01-25

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

liraglutide

5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data

DRUG

liraglutide

5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data

DRUG

liraglutide

5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily

DRUG

placebo

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2004-03-31
Completion
2004-03-31

Countries

  • Japan

Study Locations

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Entities

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620476 on ClinicalTrials.gov