Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: digoxin; Drug: griseofulvin; Drug: atorvastatin; Drug: placebo; Drug: liraglutide; Drug: lisinopril

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518166

NN2211-1608

2006-000175-15 (EudraCT Number)

Details and patient eligibility

About

The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®), griseofulvin and digoxin (Lanoxin®).

Enrollment: 70 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects if using adequate anti-contraception or is sterile
• Body Mass Index (BMI) of 18-30 kg/m^2 (both inclusive)
• 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
• Willing and capable to self-administer a subcutaneous injection

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 trial, as judged by the investigator
• Impaired renal function
• Blood pressure and heart rate in supine position outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min
• Any clinically significant abnormal ECG
• Active hepatitis B and/or active hepatitis C
• Positive HIV (human immunodeficiency virus) antibodies
• Known or suspected allergy to trial product(s) or related products
• Use of any prescription or non-prescription medication except for paracetamol, nasal spray or drops for nasal congestion, and vitamins within 2 weeks prior to first dosing and during the entire trial period
• 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

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70 participants in 2 patient groups

Trial period A

Experimental group

Treatment:

Drug: atorvastatin

Drug: placebo

Drug: lisinopril

Drug: liraglutide

Trial period B

Experimental group

Treatment:

Drug: digoxin

Drug: placebo

Drug: griseofulvin

Drug: liraglutide