Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT00563732
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500836', 'term': 'lecozotan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-08', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-23', 'lastUpdatePostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects'}]}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects.\n\nSecondary: To assess the safety and tolerability of the coadministration of lecozotan SR and digoxin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of non childbearing potential and men aged 18 to 55 years at screening.\n* Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight 50 kg (BMI = weight (kg)/\\[height (m)\\]\n\nExclusion Criteria:\n\n* Presence or history of any disorder that may prevent the successful completion of the study.\n* Any clinically important deviation from normal limits in physical examination, vital signs or clinical laboratory test results.'}, 'identificationModule': {'nctId': 'NCT00563732', 'briefTitle': 'Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'An Open-Label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Lecozotan SR and a Single Oral Dose of Digoxin When Administered Orally to Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '3098B1-1142'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lecozotan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}