Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00426920
Status:
UNKNOWN
Last Update Posted:
2007-01-25
First Post:
2007-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'lastUpdateSubmitDate': '2007-01-24', 'studyFirstSubmitDate': '2007-01-24', 'studyFirstSubmitQcDate': '2007-01-24', 'lastUpdatePostDateStruct': {'date': '2007-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum insulin serum concentration'}, {'measure': 'early T50%'}, {'measure': 'late T50%'}, {'measure': 'Tmax'}, {'measure': 'AUC'}], 'secondaryOutcomes': [{'measure': 'maximum glucose infusion rate'}, {'measure': 'early T50%'}, {'measure': 'late T50%'}, {'measure': 'Tmax'}, {'measure': 'AUC'}]}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'pharmacodynamics', 'inhaled', 'recombinant human insulin'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.', 'detailedDescription': 'Explorative, single-center, randomized, open label, 4-way crossover study to evaluate the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* non smoking for at least 12 months\n* BMI equal to or less than 28\n* no clinically significant abnormalities\n* FVC and FEV1 equal to or more than 80%\n* willing to participate and to sign informed consent form\n\nExclusion Criteria:\n\n* positive results for insulin antibodies at screening\n* history of substance abuse or dependency within last 5 years\n* positive screening test for substance abuse\n* positive blood test for HIV, hepatitis B or hepatitis C antibody\n* fasting blood glucose of more than 126mg/dl\n* any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication\n* history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality\n* has received investigational medications within 21 days prior to receiving the first dose of study medication\n* has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication\n* has taken or used any OTC medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication\n* health that may be adversely affected by procedures or medications used in the study\n* unwillingness or inability to understand or to follow required study restrictions and procedures'}, 'identificationModule': {'nctId': 'NCT00426920', 'briefTitle': 'Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler', 'organization': {'class': 'INDUSTRY', 'fullName': 'QDose Limited'}, 'officialTitle': 'Evaluation of the Pharmacokinetics and Pharmacodynamics of Spray-Dried Recombinant Human Insulin Powder for Inhalation Administered Via a Dry Powder Inhalation Device Relative to SC Recombinant Human Insulin in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'IOV/QD001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Insulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Marcus hompesch, MD', 'role': 'CONTACT', 'phone': '619-427-1300'}, {'name': '24-hour emergency number', 'role': 'CONTACT', 'phone': '619-409-1277'}, {'name': 'Marcus Hompesch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Profil Institute for Clinical Research Incorporated', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], 'centralContacts': [{'name': 'Marcus Hompesch, MD', 'role': 'CONTACT', 'phone': '619-427-1300'}, {'name': '24-hour emergency number', 'role': 'CONTACT', 'phone': '619-409-1277'}], 'overallOfficials': [{'name': 'Marcus Hompesch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institute for Clinical Research Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QDose Limited', 'class': 'INDUSTRY'}}}}