Safety and Tolerability of Liraglutide in Healthy Male Volunteers

A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01507272

Enrollment

Registered

2012-01-10

Start date

1999-03-31

Completion date

1999-12-31

Last updated

2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief 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).

Interventions

DRUGliraglutide

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Male subjects of any ethnic origin * Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject) * Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram) * Body mass index within the range 20-27 kg/m\^2, inclusive

Exclusion criteria

* Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG * History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug * Alcohol intake within 48 hours of visit * Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies * History of significant drug allergy or drug hypersensitivity * Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period * Subjects who drink more than 8 cups of tea/coffee per day

Design outcomes

Primary

Measure	Time frame
AUC (area under the curve)	—

Secondary

Measure	Time frame
Cmax, maximum concentration	—
tmax, time to maximum concentration	—
t½, terminal half-life	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026