Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 9:26 AM
Study NCT ID:
NCT06895356
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': 'Up to approximately 53 days', 'description': 'An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Tavapadon', 'timeFrame': 'Up to approximately 22 days', 'description': '(Cmax) of Tavapadon'}, {'measure': 'Time to Cmax (Tmax) of Tavapadon', 'timeFrame': 'Up to approximately 22 days', 'description': 'Tmax of Tavapadon'}, {'measure': 'Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon', 'timeFrame': 'Up to approximately 22 days', 'description': 'Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon'}, {'measure': 'Terminal Phase Elimination Half-life (t1/2) of Tavapadon', 'timeFrame': 'Up to approximately 22 days', 'description': 'Terminal Phase Elimination Half-life (t1/2) of Tavapadon'}, {'measure': 'Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon', 'timeFrame': 'Up to approximately 22 days', 'description': 'Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon', 'timeFrame': 'Up to approximately 22 days', 'description': 'Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon'}, {'measure': 'Trough Concentration (Ctrough) of Tavapadon', 'timeFrame': 'Up to approximately 22 days', 'description': 'Trough Concentration (Ctrough) of Tavapadon'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M25-974', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG\n* Females, Non-Childbearing Potential due to meeting the following criteria:\n\n * Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy.\n * Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.\n * Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU/L.\n\nExclusion Criteria:\n\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity rating scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.\n* Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.'}, 'identificationModule': {'nctId': 'NCT06895356', 'briefTitle': 'A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets', 'orgStudyIdInfo': {'id': 'M25-974'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tavapadon: Part 1-Sequence 1', 'description': 'Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2', 'interventionNames': ['Drug: Tavapadon']}, {'type': 'EXPERIMENTAL', 'label': 'Tavapadon: Part 1-Sequence 2', 'description': 'Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2', 'interventionNames': ['Drug: Tavapadon']}, {'type': 'EXPERIMENTAL', 'label': 'Tavapadon: Part 2-Sequence 1', 'description': 'Participants will receive Clinical Tavapadon Dose C in Period 1, Clinical Tavapadon Dose D in Period 2 followed by Commercial Tavapadon Dose E in Period 3', 'interventionNames': ['Drug: Tavapadon']}, {'type': 'EXPERIMENTAL', 'label': 'Tavapadon: Part 2-Sequence 2', 'description': 'Participants will receive Clinical Tavapadon Dose C in Period 1, Commercial Tavapadon Dose E in Period 2 followed by Clinical Tavapadon Dose D in Period 3', 'interventionNames': ['Drug: Tavapadon']}], 'interventions': [{'name': 'Tavapadon', 'type': 'DRUG', 'description': 'Oral: Tablet', 'armGroupLabels': ['Tavapadon: Part 1-Sequence 1', 'Tavapadon: Part 1-Sequence 2', 'Tavapadon: Part 2-Sequence 1', 'Tavapadon: Part 2-Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 275870', 'geoPoint': {'lat': 42.34447, 'lon': -88.04175}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}