Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-21 @ 1:55 AM
Study NCT ID:
NCT01518166
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2012-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D006118', 'term': 'Griseofulvin'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2012-01-17', 'studyFirstSubmitQcDate': '2012-01-21', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '26426736', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': '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®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects if using adequate anti-contraception or is sterile\n* Body Mass Index (BMI) of 18-30 kg/m\\^2 (both inclusive)\n* 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\n* Willing and capable to self-administer a subcutaneous injection\n\nExclusion Criteria:\n\n* 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\n* Impaired renal function\n* 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\n* Any clinically significant abnormal ECG\n* Active hepatitis B and/or active hepatitis C\n* Positive HIV (human immunodeficiency virus) antibodies\n* Known or suspected allergy to trial product(s) or related products\n* 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\n* History of alcoholism or drug abuse during the last 12 months\n* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products\n* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator'}, 'identificationModule': {'nctId': 'NCT01518166', 'briefTitle': 'Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'NN2211-1608'}, 'secondaryIdInfos': [{'id': '2006-000175-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trial period A', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo', 'Drug: atorvastatin', 'Drug: lisinopril']}, {'type': 'EXPERIMENTAL', 'label': 'Trial period B', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo', 'Drug: griseofulvin', 'Drug: digoxin']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Trial period A', 'Trial period B']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively', 'armGroupLabels': ['Trial period A', 'Trial period B']}, {'name': 'atorvastatin', 'type': 'DRUG', 'description': 'One single dose of 40 mg. Tablet', 'armGroupLabels': ['Trial period A']}, {'name': 'lisinopril', 'type': 'DRUG', 'description': 'One single dose of 20 mg. Tablet', 'armGroupLabels': ['Trial period A']}, {'name': 'griseofulvin', 'type': 'DRUG', 'description': 'One single dose of 500 mg. Tablet', 'armGroupLabels': ['Trial period B']}, {'name': 'digoxin', 'type': 'DRUG', 'description': 'One single dose of 1 mg. Tablet', 'armGroupLabels': ['Trial period B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75323', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}