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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518166
• Other study ID #: NN2211-1608
• Secondary ID: 2006-000175-15
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2012
• Last updated: January 24, 2017
• Start date: May 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
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
• placebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
• atorvastatin
One single dose of 40 mg. Tablet
• lisinopril
One single dose of 20 mg. Tablet
• griseofulvin
One single dose of 500 mg. Tablet
• digoxin
One single dose of 1 mg. Tablet

Locations

Country	Name	City	State
Sweden	Novo Nordisk Investigational Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Malm-Erjefält M, Ekblom M, Vouis J, Zdravkovic M, Lennernäs 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of atorvastatin
Primary	Area under the curve of lisinopril
Primary	Area under the curve of griseofulvin
Primary	Area under the curve of digoxin
Secondary	Area under the curve of liraglutide
Secondary	Cmax, maximum concentration
Secondary	tmax, time to reach Cmax
Secondary	Terminal elimination rate constant
Secondary	Intragastric pH
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk