Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01036035
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068737', 'term': 'Tolterodine Tartrate'}, {'id': 'D010862', 'term': 'Pilocarpine'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reductions in stimulated salivary flow (SSF)', 'timeFrame': 'From Baseline'}], 'secondaryOutcomes': [{'measure': 'Determine the pharmacokinetics of tolterodine and the agonist.', 'timeFrame': 'From Baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tolterodine', 'Over active Bladder (OAB)', 'Incontinence'], 'conditions': ['Incontinence']}, 'descriptionModule': {'briefSummary': 'THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).', 'detailedDescription': 'Because of the limitations of taking two medications separated by a period of time to minimise these adverse events, two novel formulations were developed to improve compliance and ease of administration. This study will evaluate these formulations in terms of their pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and its entities on urine frequency and safety/tolerability will be assessed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males, 18 - 45 years of age.\n* BMI 20-30 m2.\n\nExclusion Criteria:\n\n* Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.\n* Clinically significant ECG, vital signs and clinical laboratory indices.'}, 'identificationModule': {'nctId': 'NCT01036035', 'briefTitle': 'Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'TheraVida, Inc.'}, 'officialTitle': 'Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects', 'orgStudyIdInfo': {'id': 'THVD-201-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B', 'description': 'Study drug', 'interventionNames': ['Drug: Pilocarpine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment D', 'description': 'Study drug', 'interventionNames': ['Drug: THVD-201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment E', 'description': 'Placebo', 'interventionNames': ['Drug: placebo capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A', 'description': 'Study Drug', 'interventionNames': ['Drug: Tolterodine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment C', 'description': 'Study Drug', 'interventionNames': ['Drug: THVD-201']}], 'interventions': [{'name': 'Tolterodine', 'type': 'DRUG', 'description': 'Comparison of different dosages of drug', 'armGroupLabels': ['Treatment A']}, {'name': 'Pilocarpine', 'type': 'DRUG', 'description': 'Comparison of different dosages of drug', 'armGroupLabels': ['Treatment B']}, {'name': 'THVD-201', 'type': 'DRUG', 'description': 'Comparison of different dosages of drug', 'armGroupLabels': ['Treatment C']}, {'name': 'THVD-201', 'type': 'DRUG', 'description': 'Comparison of different dosages of drug', 'armGroupLabels': ['Treatment D']}, {'name': 'placebo capsule', 'type': 'DRUG', 'description': 'Comparison of different dosages of drug', 'armGroupLabels': ['Treatment E']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joanne Marjason', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queensland Institute for Medical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TheraVida, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}