Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-13 @ 6:29 AM
Study NCT ID:
NCT04155567
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2019-11-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs are adverse events (AEs) that started after first dose of study drug up to Day 8', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'TAK-123 3.75 g/m^2 NaPA and NaBZ', 'description': 'TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-123 3.75 g/m^2 NaPA and NaBZ', 'description': 'TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was defined as all participants who received at least one dose of TAK-123.'}, {'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-123 3.75 g/m^2 NaPA and NaBZ', 'description': 'TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.'}], 'classes': [{'title': 'Phenylacetate', 'categories': [{'measurements': [{'value': '300.7', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Benzoate', 'categories': [{'measurements': [{'value': '233.2', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Phenylacetylglutamine', 'categories': [{'measurements': [{'value': '69.77', 'spread': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'Hippurate', 'categories': [{'measurements': [{'value': '54.13', 'spread': '18.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusion', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetics (PK) analysis set was defined as all participants who received at least one dose of TAK-123 and provided sufficient PK measurements available to estimate at least one estimable PK parameter.'}, {'type': 'PRIMARY', 'title': 'AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-123 3.75 g/m^2 NaPA and NaBZ', 'description': 'TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.'}], 'classes': [{'title': 'Phenylacetate', 'categories': [{'measurements': [{'value': '3931', 'spread': '22.6', 'groupId': 'OG000'}]}]}, {'title': 'Benzoate', 'categories': [{'measurements': [{'value': '752.6', 'spread': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Phenylacetylglutamine', 'categories': [{'measurements': [{'value': '1135', 'spread': '16.2', 'groupId': 'OG000'}]}]}, {'title': 'Hippurate', 'categories': [{'measurements': [{'value': '413.5', 'spread': '22.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusion', 'unitOfMeasure': 'hour*microgram per milliliter (h*mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set was defined as all participants who received at least one dose of TAK-123 and provided sufficient PK measurements available to estimate at least one estimable PK parameter.'}, {'type': 'PRIMARY', 'title': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-123 3.75 g/m^2 NaPA and NaBZ', 'description': 'TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.'}], 'classes': [{'title': 'Phenylacetate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3932', 'spread': '22.6', 'groupId': 'OG000'}]}]}, {'title': 'Benzoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phenylacetylglutamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1140', 'spread': '16.4', 'groupId': 'OG000'}]}]}, {'title': 'Hippurate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '427.3', 'spread': '21.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusion', 'unitOfMeasure': 'h*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set was defined as all participants who received at least one dose of TAK-123 and provided sufficient PK measurements available to estimate at least one estimable PK parameter. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAK-123 3.75 g/m^2 NaPA and NaBZ', 'description': 'TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in Japan from 13 November 2019 to 06 December 2019.', 'preAssignmentDetails': 'Healthy Japanese male participants were enrolled in the study to receive TAK-123 3.75 gram per square meter (g/m\\^2) sodium phenylacetate (NaPA) and 3.75 g/m\\^2 sodium benzoate (NaBZ), as loading dose followed by an equivalent maintenance dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TAK-123 3.75 g/m^2 NaPA and NaBZ', 'description': 'TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\\^2 NaPA and TAK-123 3.75 g/m\\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33.1', 'spread': '5.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '173.7', 'spread': '5.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65.68', 'spread': '6.994', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21.74', 'spread': '1.532', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m˄2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Former Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Classification', 'classes': [{'title': 'Drank A Few Times Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Never Drank', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Caffeine Classification', 'classes': [{'title': 'Had Caffeine Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Had No Caffeine Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set was defined as all participants who received at least one dose of TAK-123.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-10', 'size': 1319650, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-29T22:30', 'hasProtocol': True}, {'date': '2019-12-12', 'size': 915056, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-29T22:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2019-11-06', 'resultsFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-02-02', 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)', 'timeFrame': 'Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusion'}, {'measure': 'AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)', 'timeFrame': 'Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusion'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)', 'timeFrame': 'Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusion'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 up to Day 8'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b603c4db2bf003ab4a363', 'label': 'Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the PK, safety and tolerability of phenylacetate and benzoate after intravenous administration of TAK-123 in Japanese healthy adult male participants.', 'detailedDescription': 'The drug being tested in this study is called TAK-123. TAK-123 is being tested in Japanese healthy adult men. This study will look at the PK, safety and tolerability of phenylacetate and benzoates of people who administered TAK-123.\n\nThe study will enroll approximately 10 participants. All participants will be administered TAK-123 intravenously at the dose level of 3.75 g/m\\^2 of sodium phenylacetate and 3.75 g/m\\^2 of sodium benzoate.\n\n\\- TAK-123 as 3.75 g/m\\^2 of sodium phenylacetate and 3.75 g/m\\^2 of sodium benzoate\n\nThis single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 8 days. Participants will make multiple visits to the clinic and be hospitalized for four days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participant is capable of understanding and complying with protocol requirements in the opinion of the investigator or sub-investigator.\n2. The participant signs and dates a written informed consent form prior to the initiation of any study procedures.\n3. The participant is a Japanese healthy adult male.\n4. The participant is aged 20 to 45 years inclusive at the time of informed consent.\n5. The participant weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\\^2), inclusive, at Screening.\n6. The participant is sterile, vasectomized or agrees to use an appropriate method of contraception throughout the treatment period.\n\nExclusion Criteria:\n\n1. The participant has received any investigational drugs within 90 days before screening for this study (including the cases that at least 5 times the elimination half-lives of any investigational drugs have not yet passed).\n2. The participant previously received TAK-123, its ingredients, or related compound before participation in this study except for the cases where benzoic acid is ingested as a food additive.\n3. The participant is an employee of the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or who may be forced to provide consent.\n4. The participants have previous or current history of diseases that may affect the participation in this study or study results, including uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, endocrine, hematologic, immune, skin disease or psychiatric disorder.\n5. The participant has a history of multiple episodes or severe allergies (example, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription drugs, over-the-counter (OTC) drugs or foods.\n6. The participant has had an anaphylactic reaction to active ingredients or additives of TAK-123, ondansetron or additives of ondansetron, or salicylic acid associated with the intravenous administration of TAK-123.\n7. The participant has a positive urine drug test at the time of screening.\n8. The participant has a history of drug abuse (defined as any illicit drug use) or has a history of alcohol dependence within 2 years before the start of screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.\n9. The participant consumes 6 or more servings of caffeinated beverages (containing about 720 milligram \\[mg\\] of caffeine or more) such as coffee, tea, cola, or energy drinks per day.\n10. The participant is a smoker who smoked cigarettes or used nicotine-containing products (such as nicotine patch) within 6 months before the study drug administration.\n11. The participant has a history of cancer.\n12. The participant has a positive test result for any of the following at the time of screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis.\n13. The participant has poor peripheral venous access.\n14. The participant has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study drug administration.\n15. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of the study drug administration.\n16. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration.\n17. The participant has any clinically relevant abnormality in vital signs or 12-lead electrocardiogram (ECG) at screening or predose of Day 1.\n18. The participant has abnormal laboratory test values at screening indicating clinically relevant underlying disease, or showing alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\>1.5 × upper limit of normal (ULN).\n19. The participant has been on an abnormal diet (example, excessive drinking and eating or starvation condition) during the four weeks (28 days) prior to the start of the study drug administration in the opinion of the investigator or sub-investigator.\n20. The participant who used or plans to use excluded concomitant medications, supplements, or dietary products during the predefined period in this study.\n21. The participant is unlikely to comply with the protocol requirements or is unsuitable as a participant of this study for any other reason in the opinion of the investigator or sub-investigator.'}, 'identificationModule': {'nctId': 'NCT04155567', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Single Center, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Subjects', 'orgStudyIdInfo': {'id': 'TAK-123-1001'}, 'secondaryIdInfos': [{'id': 'U1111-1237-4920', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-195027', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-123', 'description': 'TAK-123 as 3.75 gram per square meter (g/m\\^2) of sodium phenylacetate and 3.75 g/m\\^2 of sodium benzoate, intravenous administration over 90 minutes, followed by TAK-123 as 3.75 g/m\\^2 of sodium phenylacetate and 3.75 g/m\\^2 of sodium benzoate, intravenous administration over 24 hours.', 'interventionNames': ['Drug: TAK-123']}], 'interventions': [{'name': 'TAK-123', 'type': 'DRUG', 'description': 'TAK-123 infusion', 'armGroupLabels': ['TAK-123']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Sekino Clinical Pharmacology Clinic'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}