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

NCT01620463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-01-24

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 NNC 90-1170 (liraglutide) in healthy Japanese male subjects.

Conditions

Interventions

DRUG

liraglutide

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

DRUG

placebo

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

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
2002-12-31
Primary Completion
2003-03-31
Completion
2003-03-31

Countries

  • Japan

Study Locations

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Entities

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 NCT01620463 on ClinicalTrials.gov