Comparison of Three Liraglutide Formulations in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514487

NN2211-1636

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

24 participants in 3 patient groups

pH 7.7

Experimental group

Treatment:

Drug: liraglutide

pH 7.9

Experimental group

Treatment:

Drug: liraglutide

pH 8.15

Experimental group

Treatment:

Drug: liraglutide