Clinical trial NCT01518166: Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH
Official title: A Two-way Cross-over, Placebo-controlled Interaction Trial in Two Parts (in Healthy Subjects), Studying Liraglutide's Potential Influence on the Absorption Pharmacokinetics of Lisinopril, Atorvastatin, Griseofulvin and Digoxin, and Liraglutide's Potential Influence on Intragastric pH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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®).


Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve of atorvastatin
measure: Area under the curve of lisinopril
measure: Area under the curve of griseofulvin
measure: Area under the curve of digoxin
Secondary outcomes:
measure: Area under the curve of liraglutide
measure: Cmax, maximum concentration
measure: tmax, time to reach Cmax
measure: Terminal elimination rate constant
measure: Intragastric pH
measure: Adverse events
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Malm-Erjefalt M, Ekblom M, Vouis J, Zdravkovic M, Lennernas H. Effect on the Gastrointestinal Absorption of Drugs from Different Classes in the Biopharmaceutics Classification System, When Treating with Liraglutide. Mol Pharm. 2015 Nov 2;12(11):4166-73. doi: 10.1021/acs.molpharmaceut.5b00278. Epub 2015 Oct 12.