Comparison of Three Liraglutide Formulations in Healthy Volunteers

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: liraglutide

• Registration Number: NCT01514487
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-13
• Primary Completion: 2005-03-30
• Study Completion: 2005-03-30
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy subjects
• Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.
• Body Mass Index (BMI) of 18-27 kg/m^2, both inclusive

Exclusion Criteria

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,
• metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders
• that may interfere with the objectives of the study, as judged by the investigator
• Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
• Impaired renal function
• Uncontrolled treated/untreated hypertension
• Any clinically significant abnormal ECG
• Active hepatitis B and/or active hepatitis C
• Positive HIV (human immunideficiency virus) antibodies
• Known or suspected allergy to trial product(s) or related products
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
• Prescription or non-prescription medication, except for paracetamol and vitamins
• History of alcoholism or drug abuse during the last 12 months
• Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pH 7.7	liraglutide	-
pH 7.9	liraglutide	-
pH 8.15	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Area under the Curve (0-t)
Cmax, maximum concentration

Secondary Outcome Measures

Name	Time	Method
Area under the curve (0-infinity)
tmax, time to reach Cmax
t½, terminal half-life
Terminal elimination rate constant
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇺 Adelaide, Australia