Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:15 AM
Study NCT ID:
NCT07486895
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of Centanafadine', 'timeFrame': 'Up to Day 5'}, {'measure': 'Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine', 'timeFrame': 'Up to Day 5'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine', 'timeFrame': 'Up to Day 5'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine', 'timeFrame': 'Up to Day 5'}, {'measure': 'Percentage (%) of Extrapolated AUC of Centanafadine', 'timeFrame': 'Up to Day 5'}, {'measure': 'Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine', 'timeFrame': 'Up to Day 5'}, {'measure': 'Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine', 'timeFrame': 'Up to Day 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'Attention-deficit/hyperactivity disorder'], 'conditions': ['Healthy Adult Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\\^2) (inclusive).\n2. In good health as determined by:\n\n 1. Medical history\n 2. Physical examination\n 3. Electrocardiogram (ECG)\n 4. Serum/urine chemistry, hematology, and serology tests.\n3. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.\n\nExclusion Criteria\n\n1. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.\n2. History of drug and/or alcohol abuse within 2 years prior to screening.\n3. History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.\n4. History of any significant drug allergy or known or suspected hypersensitivity.\n5. Participants having taken an investigational drug within 30 days prior to screening.\n6. Previous exposure to centanafadine.\n7. Any history of significant bleeding or hemorrhagic tendencies.\n8. A history of difficulty in donating blood.\n9. The donation of blood or plasma within 30 days prior to the first dose of investigational medical product (IMP).\n10. Use of prescription, over-the-counter, herbal medication or vitamin supplements within 14 days prior to the first dose of IMP and antibiotics within 30 days prior to the first dose of IMP.\n11. Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT07486895', 'briefTitle': 'Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'An Open-label, Randomized, Crossover Trial in Healthy Subjects to Assess Dose Strength Equivalence Among 164.4 and 328.8 mg Strengths of Oral Centanafadine QD XR Capsules', 'orgStudyIdInfo': {'id': '405-201-00102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR', 'description': 'Participants will first receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 1, followed by 2 × 164.4 mg centanafadine QD XR capsules administered orally once daily on Day 5.', 'interventionNames': ['Drug: Centanafadine']}, {'type': 'EXPERIMENTAL', 'label': 'CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR', 'description': 'Participants will first receive 2 × 164.4 mg centanafadine QD XR capsule, orally on Day 1. Then, they will receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 5.', 'interventionNames': ['Drug: Centanafadine']}], 'interventions': [{'name': 'Centanafadine', 'type': 'DRUG', 'description': 'Centanafadine will be administered as an oral capsule.', 'armGroupLabels': ['CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR', 'CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'ICON plc', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}]}, 'ipdSharingStatementModule': {'url': 'https://clinical-trials.otsuka.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.', 'ipdSharing': 'YES', 'description': 'Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.', 'accessCriteria': 'Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}