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

NCT01518166 | Completed Phase 1

• 2 other identifiers: NN2211-16082006-000175-15
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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®).

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Area under the curve of liraglutide

• Cmax, maximum concentration

• tmax, time to reach Cmax

• Terminal elimination rate constant

• Intragastric pH

Study Arms (2)

Trial period A

EXPERIMENTAL

Drug: liraglutide; Drug: placebo; Drug: atorvastatin; Drug: lisinopril

Trial period B

EXPERIMENTAL

Drug: liraglutide; Drug: placebo; Drug: griseofulvin; Drug: digoxin

Interventions

liraglutide DRUG

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

Trial period A; Trial period B

placebo DRUG

Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively

Trial period A; Trial period B

atorvastatin DRUG

One single dose of 40 mg. Tablet

Trial period A

lisinopril DRUG

One single dose of 20 mg. Tablet

Trial period A

griseofulvin DRUG

One single dose of 500 mg. Tablet

Trial period B

digoxin DRUG

One single dose of 1 mg. Tablet

Trial period B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Uppsala, 75323, Sweden

Location

Related Publications (1)

• 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.

  PMID: 26426736 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Liraglutide; Atorvastatin; Lisinopril; Griseofulvin; Digoxin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 25, 2012
• Study Start: May 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

SE (1)