Diabetes, Healthy
Conditions
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®).
Interventions
DRUGliraglutide
Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3
DRUGplacebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
DRUGatorvastatin
One single dose of 40 mg. Tablet
DRUGlisinopril
One single dose of 20 mg. Tablet
DRUGgriseofulvin
One single dose of 500 mg. Tablet
DRUGdigoxin
One single dose of 1 mg. Tablet
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Intragastric pH | — |
| Area under the curve of liraglutide | — |
| Adverse events | — |
| Cmax, maximum concentration | — |
| tmax, time to reach Cmax | — |
| Terminal elimination rate constant | — |
Countries
Sweden
Outcome results
None listed