Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-04-05 @ 12:40 AM
Study NCT ID:
NCT01054261
Status:
COMPLETED
Last Update Posted:
2011-01-07
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C553414', 'term': 'avanafil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-05', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-01-21', 'lastUpdatePostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single dose PK of avanafil', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['avanafil, renal, impairment, TA-1790'], 'conditions': ['Renal']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment and to assess the safety and toleration of avanafil in subjects with mild and moderate renal impairment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male subjects,\n* 21-78 years of age, must be medically healthy with no clinically significant screening results (except for the subjects in Groups 2 and 3).\n* Subjects with normal renal function (Group 1) must have an estimated CLcr of ≥80 mL/min.\n* Subjects with renal impairment (Groups 2 and 3) must fulfill the additional following criteria: (a) Stable renal impairment; (b) Group 2 subjects with mild renal impairment must have a CLcr of ≥50 to \\<80 mL/min and (c) Group 3 subjects with moderate renal impairment must have a CLcr of ≥30 to \\<50 mL/min.\n\nExclusion Criteria:\n\n* Major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal (with the exception of renal insufficiency for subjects in Groups 2 and 3), hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the Investigator; systolic blood pressure \\< 90 or \\>160 mmHg; diastolic blood pressure \\< 50 or \\> 95 mmHg; allergy to or previous adverse events with PDE5 inhibitors or its constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days prior to Day 1; use of any investigational drug within 30 days prior to Day 1; use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breathe alcohol test; positive cotinine test, positive urine drug screen (except in renally impaired subjects following approval by Sponsor). Additional exclusion criteria are listed in Section 4.2.'}, 'identificationModule': {'nctId': 'NCT01054261', 'briefTitle': 'To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIVUS LLC'}, 'officialTitle': 'A Phase I, Open-Label, Parallel-Group, Single Dose, Non-Randomized Study to Compare the Pharmacokinetics of Avanafil in Male Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function', 'orgStudyIdInfo': {'id': 'TA-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Normal', 'description': 'Normal renal function', 'interventionNames': ['Drug: avanafil']}, {'type': 'OTHER', 'label': 'Mild', 'description': 'Mild renal impairment', 'interventionNames': ['Drug: avanafil']}, {'type': 'OTHER', 'label': 'Moderate', 'description': 'Moderate renal impairment', 'interventionNames': ['Drug: avanafil']}], 'interventions': [{'name': 'avanafil', 'type': 'DRUG', 'description': '200 mg avanafil tablet QD', 'armGroupLabels': ['Mild', 'Moderate', 'Normal']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shiyin Yee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VIVUS LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVUS LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wesley Day', 'oldOrganization': 'VP Clinical Operations'}}}}