MedTrace Logo

Safety and Tolerability of Liraglutide in Healthy Male Volunteers

NCT01507272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-01-24

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

liraglutide

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

DRUG

liraglutide

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

DRUG

placebo

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

DRUG

placebo

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

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
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Primary Completion
1999-12-31
Completion
1999-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01507272 on ClinicalTrials.gov