Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-31 @ 3:27 AM
Study NCT ID:
NCT00854659
Status:
COMPLETED
Last Update Posted:
2010-11-02
First Post:
2009-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C528492', 'term': 'ABT 102'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.', 'timeFrame': '10 days'}, {'measure': 'To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects.', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '21377273', 'type': 'DERIVED', 'citation': 'Rowbotham MC, Nothaft W, Duan RW, Wang Y, Faltynek C, McGaraughty S, Chu KL, Svensson P. Oral and cutaneous thermosensory profile of selective TRPV1 inhibition by ABT-102 in a randomized healthy volunteer trial. Pain. 2011 May;152(5):1192-1200. doi: 10.1016/j.pain.2011.01.051. Epub 2011 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of three different strengths of an investigational product dosed twice a day over 7 days in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females with a condition of general good health.\n* Must be willing to participate in all study-related procedures.\n\nExclusion Criteria:\n\n* History of significant sensitivity to any drug.\n* Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives.\n* A requirement for medications, vitamins and/or herbal supplements during the study.\n* Pregnant or breast-feeding.\n* History of drug or alcohol abuse.\n* Positive Hepatitis or HIV test.\n* History of certain medical conditions or any uncontrolled medical illness.\n* History of certain gastrointestinal surgeries that may interfere with gastrointestinal motility, PH or absorption.\n* Current participation in another clinical study or receipt of investigational drug within the past 6 weeks.'}, 'identificationModule': {'nctId': 'NCT00854659', 'briefTitle': 'A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'M10-613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'ABT-102 Tablets, 4 mg BID', 'interventionNames': ['Drug: ABT-102']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'ABT-102 Tablets BID, escalating dose', 'interventionNames': ['Drug: ABT-102']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'ABT-102 Tablets BID, escalating dose', 'interventionNames': ['Drug: ABT-102']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Placebo Tablets, BID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ABT-102', 'type': 'DRUG', 'description': 'BID tablets, 7 days of treatment', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'BID tablets, 7 days of treatment', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 18101', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wolfram Nothaft, MD / Project Director', 'oldOrganization': 'Abbott'}}}}