Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT04100759
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2019-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-22', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2019-09-22', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum drug concentration in plasma (Cmax)', 'timeFrame': 'up to 3 hours post-dose', 'description': 'Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)', 'timeFrame': 'up to 24 hours post-dose', 'description': 'Area under the plasma concentration-time curve from time 0 to time(t) measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)'}], 'secondaryOutcomes': [{'measure': 'Time to Maximum drug concentration in plasma (tmax)', 'timeFrame': 'up to 3 hours post-dose', 'description': 'Time corresponding to maximum drug concentration in plasma measured in Hours(h)'}, {'measure': 'Elimination half life of drug in plasma ( t½)', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Elimination half life of drug measured in Hours(hr)'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to infinity', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Area under the plasma concentration-time curve from time 0 to infinity measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction', 'Smoking', 'Pharmacokinetics', 'Pharmacodynamics']}, 'descriptionModule': {'briefSummary': 'Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.', 'detailedDescription': 'The study is a randomized, single dose, one way, open label, parallel study in thirty-six (36) subjects randomized into three groups;group(1) included twelve(12) healthy non-smoker males, group(2) included twelve(12) healthy smokers (Cigarettes) and group(3) included twelve(12) healthy smokers (marijuana).\n\nEach group received a single dose of Viagra 50 mg film coated tablet (Sildenafil 50 mg) Blood samples were collected at the following sampling intervals: pre-dose administration, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8,10, 12 and 24 hours post dose.\n\nBlood samples were centrifuged and plasma was separated and stored at -80 degree Celsius till time of analysis.\n\nPlasma concentrations of sildenafil were determined by liquid chromatography tandem mass spectrometry (LC/MS/MS)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'subjects are to provide their national IDs to confirm that subjects are male subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects\n* Age 18-55 years.\n* Ideal weight with ideal body mass index(BMI).\n* Non-contributory history and normal physiological examination.\n* Laboratory data within normal limits.\n* Performance and compliance.\n* The subjects should be without known history of alcohol or drug abuse problems\n* Subjects who are cigarette smokers\n* Subjects who are cannabis smokers\n* Subjects who are non-smokers\n\nExclusion Criteria:\n\n* A known hypersensitivity to the drug.\n* Gastrointestinal diseases.\n* Auto immune diseases.\n* Renal diseases or dysfunction.\n* Cardiovascular disease of any type.\n* Pancreatic disease including diabetes.\n* Hepatic disease.\n* Hematological, osteopathic, or pulmonary disease.\n* History of alcoholism or drug abuse.\n* Serious Psychological illness.\n* Positive HIV.\n* Abnormal (out of range) laboratory values.\n* Subject who have taken any medication less than two weeks of the trials starting date.\n* Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.'}, 'identificationModule': {'nctId': 'NCT04100759', 'briefTitle': 'A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Pharmacokinetics and Pharmacodynamics of Sildenafil in Adult Smokers and Non-smokers', 'orgStudyIdInfo': {'id': 'SIL-RES-0119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-Smokers', 'description': 'Subjects administer one tablet of sildenafil 50 mg', 'interventionNames': ['Drug: Sildenafil 50 mg Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Cigarette Smokers', 'description': 'Subjects administer one tablet of sildenafil 50mg', 'interventionNames': ['Drug: Sildenafil 50 mg Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Cannabis Smokers', 'description': 'Subjects administer one tablet of sildenafil 50mg', 'interventionNames': ['Drug: Sildenafil 50 mg Oral Tablet']}], 'interventions': [{'name': 'Sildenafil 50 mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Viagra 50 mg film coated tablets'], 'description': 'Sildenafil 50 mg Oral Tablet', 'armGroupLabels': ['Cannabis Smokers', 'Cigarette Smokers', 'Non-Smokers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Sheraton Heliopolis', 'country': 'Egypt', 'facility': 'Drug Research Centre', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Nagwa A Sabri, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ainshams university'}, {'name': 'Mohammed M Hussein, Msc student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ainshams university'}, {'name': 'Mohamed A Raslan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drug Research Centre, Cairo, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Drug Research Centre, Cairo, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'QC Manager and Clinical pharmacy Msc student', 'investigatorFullName': 'Mohamed Raslan', 'investigatorAffiliation': 'Drug Research Centre, Cairo, Egypt'}}}}