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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: liraglutide; Drug: placebo; Drug: atorvastatin; Drug: griseofulvin; Drug: lisinopril; Drug: digoxin

• Registration Number: NCT01518166
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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®).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-21
• Study First Posted: 2012-01-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trial period A	liraglutide	-
Trial period A	placebo	-
Trial period A	atorvastatin	-
Trial period B	placebo	-
Trial period B	liraglutide	-
Trial period B	griseofulvin	-
Trial period A	lisinopril	-
Trial period B	digoxin	-

Primary Outcome Measures

Name	Time	Method
Area under the curve of atorvastatin
Area under the curve of lisinopril
Area under the curve of griseofulvin
Area under the curve of digoxin

Secondary Outcome Measures

Name	Time	Method
Cmax, maximum concentration
Terminal elimination rate constant
Intragastric pH
Adverse events
Area under the curve of liraglutide
tmax, time to reach Cmax

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Uppsala, Sweden