{"protocolSection":{"identificationModule":{"nctId":"NCT02369172","orgStudyIdInfo":{"id":"M522101-EU25"},"organization":{"fullName":"Maruho Europe Limited","class":"INDUSTRY"},"briefTitle":"Drug-Drug Interaction Study: ASP2151 and Bupropion","officialTitle":"A Single-centre, Open-label Study in Healthy Men to Investigate the Effect of Repeated Oral Doses of ASP2151 on the Pharmacokinetics of Bupropion"},"statusModule":{"statusVerifiedDate":"2019-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-02"},"primaryCompletionDateStruct":{"date":"2015-04","type":"ACTUAL"},"completionDateStruct":{"date":"2015-04","type":"ACTUAL"},"studyFirstSubmitDate":"2015-02-16","studyFirstSubmitQcDate":"2015-02-16","studyFirstPostDateStruct":{"date":"2015-02-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-07-09","resultsFirstSubmitQcDate":"2018-07-09","resultsFirstPostDateStruct":{"date":"2019-01-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-01-31","lastUpdatePostDateStruct":{"date":"2019-02-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Maruho Europe Limited","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"CYP2B6 is involved in the metabolism of many drugs. So, it is important to assess in vivo the effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2B6 probe substrate bupropion."},"conditionsModule":{"conditions":["Healthy"],"keywords":["Herpes","volunteers","drug-drug interaction"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion + ASP2151","type":"OTHER","description":"400 mg ASP2151 followed by 150 mg Bupropion","interventionNames":["Drug: Bupropion","Drug: ASP2151"]}],"interventions":[{"type":"DRUG","name":"Bupropion","armGroupLabels":["Bupropion + ASP2151"],"otherNames":["Zyban"]},{"type":"DRUG","name":"ASP2151","armGroupLabels":["Bupropion + ASP2151"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Peak Plasma Concentration (Cmax) of Bupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Bupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"}],"secondaryOutcomes":[{"measure":"Number of Participants With Serious and Non-Serious Adverse Events","description":"Refer to the result of adverse event.","timeFrame":"Up to 32 days after the last dose"}],"otherOutcomes":[{"measure":"Peak Plasma Concentration (Cmax) of Hydroxybupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Time of Peak Concentration (Tmax) of Hydroxybupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of Hydroxybupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Hydroxybupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Half-life (t1/2) of Hydroxybupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Trough Plasma Concentration (Ctrough) of ASP2151","timeFrame":"Days 6-14 and at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Peak Plasma Concentration (Cmax) of ASP2151","timeFrame":"prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Time of Peak Concentration (Tmax) of ASP2151","timeFrame":"prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau) of ASP2151","timeFrame":"prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of ASP2151","timeFrame":"prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Half-life (t1/2) of ASP2151","timeFrame":"prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Apparent Volume of Distribution (Vd/F) of ASP2151","timeFrame":"prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Apparent Total Body Clearance (CL/F) of ASP2151","timeFrame":"prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15"},{"measure":"Time of Peak Concentration (Tmax) of Bupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Area Under the Curve Over up to Last No-zero Value (AUC0-tn) of Bupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Half-life (t1/2) of Bupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Apparent Volume of Distribution (Vd/F) of Bupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"},{"measure":"Apparent Total Body Clearance (CL/F) of Bupropion","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* A body mass index (Quetelet index) in the range 18.0-30.9.\n* Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.\n* Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.\n* Willingness to give written consent to have data entered into The Overvolunteering Prevention System.\n\nExclusion Criteria:\n\n* Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.\n* Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).\n* Platelet counts outside normal limits (129,000-346,000/μL).\n* Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.\n* Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.\n* History of bleeding diathesis, head injury, intracranial mass lesions, hydrocephalus, epilepsy, seizures, depression, self-harm (or thoughts of self-harm) or eating disorders.\n* Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.\n* Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as \\>3), or sensitivity to trial medication.\n* Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4, CYP2C8, CYP2B6, CYP2D6 or CYP2C19 metabolic pathway.\n* Use, during the 7 days before the first dose of trial medication, of any over-the-counter medicine, with the exception of paracetamol (acetaminophen).\n* Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.\n* Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly.\n* Current smoker or history of regular use of tobacco or nicotine-containing products within the previous 6 months.\n* Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40\\_100 beats/min. However, if the investigator deems the result to be not clinically significant the subject may be included.\n* Possibility that the volunteer will not cooperate with the requirements of the protocol.\n* Evidence of drug abuse on urine testing.\n* Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.\n* Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.\n* Objection by General Practitioner (GP) to volunteer entering trial.","healthyVolunteers":true,"sex":"MALE","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Hammersmith Medicines Research Ltd","city":"London","zip":"NW10 7EW","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Participants took part in the study at one investigative site in United Kingdom from 03-February 2015 to 17-April 2015","groups":[{"id":"FG000","title":"Bupropion + ASP2151","description":"400 mg ASP2151 followed by 150 mg Bupropion\n\nBupropion\n\nASP2151"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion + ASP2151","description":"400 mg ASP2151 followed by 150 mg Bupropion\n\nBupropion\n\nASP2151"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"24"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"year","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.6","spread":"7.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"24"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"23"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"18"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"24"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Peak Plasma Concentration (Cmax) of Bupropion","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29","groups":[{"id":"OG000","title":"Day 1","description":"150 mg bupropion alone"},{"id":"OG001","title":"Day 15","description":"150 mg bupropion with 400 mg ASP2151"},{"id":"OG002","title":"Day 22","description":"150 mg bupropion alone"},{"id":"OG003","title":"Day 29","description":"150 mg bupropion alone"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"91.28","spread":"27.2"},{"groupId":"OG001","value":"76.94","spread":"30.3"},{"groupId":"OG002","value":"92.21","spread":"28"},{"groupId":"OG003","value":"95","spread":"25.2"}]}]}]},{"type":"PRIMARY","title":"Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Bupropion","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"h*ng/mL","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29","groups":[{"id":"OG000","title":"Day 1","description":"150 mg bupropion alone"},{"id":"OG001","title":"Day 15","description":"150 mg bupropion with 400 mg ASP2151"},{"id":"OG002","title":"Day 22","description":"150 mg bupropion alone"},{"id":"OG003","title":"Day 29","description":"150 mg bupropion alone"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"777.6","spread":"30"},{"groupId":"OG001","value":"653.7","spread":"26.1"},{"groupId":"OG002","value":"785.5","spread":"31.1"},{"groupId":"OG003","value":"841.4","spread":"29"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Serious and Non-Serious Adverse Events","description":"Refer to the result of adverse event.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Up to 32 days after the last dose","groups":[{"id":"OG000","title":"All Subjects","description":"All subjects"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"classes":[{"title":"Non-serious adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]},{"title":"serious adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Peak Plasma Concentration (Cmax) of Hydroxybupropion","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29","groups":[{"id":"OG000","title":"Day 1","description":"150 mg bupropion alone"},{"id":"OG001","title":"Day 15","description":"150 mg bupropion with 400 mg ASP2151"},{"id":"OG002","title":"Day 22","description":"150 mg bupropion alone"},{"id":"OG003","title":"Day 29","description":"150 mg bupropion 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60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29","groups":[{"id":"OG000","title":"Day 1","description":"150 mg bupropion alone"},{"id":"OG001","title":"Day 15","description":"150 mg bupropion with 400 mg ASP2151"},{"id":"OG002","title":"Day 22","description":"150 mg bupropion alone"},{"id":"OG003","title":"Day 29","description":"150 mg bupropion alone"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10524.7","spread":"32.9"},{"groupId":"OG001","value":"10160.7","spread":"37.7"},{"groupId":"OG002","value":"11135.4","spread":"34.1"},{"groupId":"OG003","value":"10963","spread":"37.4"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of 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pre-dose"},{"id":"OG002","title":"Day 8","description":"Day 8 pre-dose"},{"id":"OG003","title":"Day 9","description":"Day 9 pre-dose"},{"id":"OG004","title":"Day 10","description":"Day 10 pre-dose"},{"id":"OG005","title":"Day 11","description":"Day 11 pre-dose"},{"id":"OG006","title":"Day 12","description":"Day 12 pre-dose"},{"id":"OG007","title":"Day 13","description":"Day 13 pre-dose"},{"id":"OG008","title":"Day 14","description":"Day 14 pre-dose"},{"id":"OG009","title":"Day 15","description":"Day 15 pre-dose"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"24"},{"groupId":"OG004","value":"24"},{"groupId":"OG005","value":"24"},{"groupId":"OG006","value":"24"},{"groupId":"OG007","value":"24"},{"groupId":"OG008","value":"24"},{"groupId":"OG009","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"244.95","spread":"104.63"},{"groupId":"OG002","value":"245.83","spread":"122.39"},{"groupId":"OG003","value":"219.17","spread":"105.83"},{"groupId":"OG004","value":"185.31","spread":"84.66"},{"groupId":"OG005","value":"199.16","spread":"105.72"},{"groupId":"OG006","value":"197.05","spread":"99.95"},{"groupId":"OG007","value":"192.66","spread":"102.29"},{"groupId":"OG008","value":"188.46","spread":"95.75"},{"groupId":"OG009","value":"178.93","spread":"87.78"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Peak 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