[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100293722":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":53,"centralContacts":35,"locations":57,"responsibleParty":70,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":35,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":35,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":35,"overallStatus":95,"whyStopped":35,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Swedish Orphan Biovitrum","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - CYP substrates","EXPERIMENTAL","In Arm A of the clinical study the potential effect of multiple doses of nitisinone on the blood concentration of the active substances tolbutamide, metoprolol and chlorzoxazone will be investigated. These substances are metabolized by CYP2C9, CYP2D6 and CYP2E, respectively.\n\nA cocktail of the substances tolbutamide, metoprolol and chlorzoxazone will be given as a single dose at the beginning of the study and PK will be investigated. The participants will then administer nitisinone for two weeks until therapeutic serum concentrations level is reached. Serum and urine concentrations of nitisinone will then be investigated for 24 hours, followed by giving the substances tolbutamide, metoprolol and chlorzoxazone as a single dose together with nitisinone to investigate the PK during interaction.",[13,14,15,16],"Drug: Nitisinone in Arm A","Drug: Tolbutamide","Drug: Metoprolol","Drug: Chlorzoxazone",{"label":18,"type":10,"description":19,"interventionNames":20},"Arm B - OAT substrates","In Arm B of the clinical study the potential effect of multiple doses of nitisinone on the blood concentration of the active substances furosemide in the blood, which is transported by the transporter proteins OAT 1 and OAT 3, will be investigated.\n\nFurosemide will be given intravenously as a single dose at the beginning of the study and PK will be investigated. The participants will then administer nitisinone for two weeks until therapeutic dose is reached. Furosemide will then be given as a single dose together with nitisinone to investigate the PK during interaction.",[21,22],"Drug: Furosemide","Drug: Nitisinone in Arm B",[24,31,36,40,44,48],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Nitisinone in Arm A","4 capsules of 20 mg nitisinone (80 mg) is given once daily for 17 days.",[9],[30],"Orfadin",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Tolbutamide","A 500 mg tablet is given as single oral dose 2 weeks apart.",[9],null,{"type":25,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Metoprolol","A 50 mg tablet of metoprolol tartrate is given as single oral dose 2 weeks apart.",[9],{"type":25,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Chlorzoxazone","A 250 mg tablet is given as single oral dose 2 weeks apart.",[9],{"type":25,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Furosemide","A single intravenous dose of 20 mg administered as an i.v. infusion is given 2 weeks apart.",[18],{"type":25,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Nitisinone in Arm B","4 capsules of 20 mg nitisinone (80 mg) is given once daily for 16 days.",[18],[30],[54],{"name":55,"affiliation":5,"role":56},"Anders Bröijersén, MD, PhD","STUDY_DIRECTOR",[58],{"facility":59,"status":35,"city":60,"state":35,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":35},"PAREXEL EPCU Berlin","Berlin","14050","Germany","DE",{"type":65,"coordinates":66},"Point",[67,68],13.41053,52.52437,{"lat":68,"lon":67},{"type":71,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[73],{"name":74,"class":6},"Parexel","100293722","phase-1-a-study-to-investigate-the-potential-influence-of-nitisinone-on-the-metabolism-and-the-transport-of-other-drugs-in-healthy-volunteers-100293722",false,"NCT03103568","A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers","An Open-label, Non-randomized, 2-arm, 2-period Fixed Sequence Phase 1 Study to Evaluate the Potential Inhibition of Nitisinone on Cytochrome P450 2C9, 2D6, and 2E1 and the Organic Anion Transporters OAT1 and OAT3 in Healthy Volunteers","Inclusion Criteria:\n\n1. Healthy male and female volunteers, 18 - 55 years of age inclusive, who are judged by the investigator to be healthy on the basis of a pre-study physical examination, which includes clinical chemistry, hematology and urinalysis, vital signs (pulse and blood pressure), and ECG.\n2. Female subject must be either:\n\n   a. Of none childbearing potential: i. post-menopausal (defined as at least 1 year without any menstruation without an alternative medical cause) , prior to Screening, or ii. documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).\n\n   b. Or, if of childbearing potential, i. must have a negative urine\u002Fserum pregnancy test at Screening, and ii. must be using highly effective methods of birth control \\[Acceptable forms of birth control include: 1) Placement of an intrauterine device (IUD) or intrauterine system (IUS). The devices must not release any hormones. (Note: The IUD must have a failure rate \\\u003C 1 %) 2) the subject's male partner has undergone effective surgical sterilization before the female subject entered the clinical trial and he is the sole sexual partner of the female subject during the clinical trial. 3) Observe abstinence (acceptable only if it is the subject's usual lifestyle). \\] (failure rate \\\u003C 1% per year when used consistently and correctly) at least 3 months prior to Screening until 4 weeks after study termination in combination with an approved barrier method \\[Approved barrier methods of contraception include: condom (without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or fat- or oil-containing lubricants), or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\\]. Women should be informed of the potential risks associated with becoming pregnant while enrolled.\n3. Male subjects must agree to use a condom when having sexual intercourse with female partners of childbearing potential during treatment and up to 4 weeks after the last dose of study treatment.\n4. Body weight 64 to 100 kg.\n5. Body mass index (BMI) 18 - 30 kg\u002Fm2\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion.\n2. Recent history or presence of clinically significant gastrointestinal, hepatic, renal, cardiovascular, hematological, metabolic, urological, pulmonary, neurological or psychiatric disorder.\n3. History of hypoglycemia.\n4. Current keratopathy, or other clinically relevant abnormalities, found by ophthalmologic slit-lamp examination.\n5. Poor or ultra-rapid metabolism of CYP2D6 substrates confirmed by genotyping (exclusion criteria for Arm A only).\n6. History of allergy, hypersensitivity or known contraindication to any of the drugs, or their excipients, used in this study.\n7. History of sulfonamide allergy.\n8. Continuous use of any non-topical medication within 1 month, over-the-counter preparations, herbal remedies , and all other medication within 14 days or less than 5 times the half-life of that medication, whichever is the longer, prior to first intake of an IMP.\n9. Daily smoking \\> 10 cigarettes.\n10. Daily consumption of more than 5 cups of coffee.\n11. History of drug and\u002For alcohol abuse.\n12. Positive drug screen or alcohol test.\n13. Positive screens for HBsAg, anti-HCV, anti-HBc Ab, HepC, HIV 1 2 antibodies.\n14. Pregnancy or breast feeding.\n15. Female subjects using hormonal contraceptives.\n16. Enrollment in another concurrent clinical study, or intake of an experimental drug, within 3 months prior to inclusion in this study.\n17. Donation of more than 400 mL of blood within 90 days prior to drug administration or donation of more than 1.5 liters of blood in the 10 months prior to first intake of an IMP.\n18. Foreseeable inability to cooperate with given instructions or study procedures.\n19. Inability to give written informed consent or to comply fully with the protocol.\n20. Vulnerable subjects, e.g., subjects kept in detention.\n21. Soldiers, investigator, employees of the Sponsor or CRO.\n22. Subject is not able to read, write and speak German.",true,"ALL","18 Years","55 Years",{"count":87,"type":88},36,"ACTUAL","INTERVENTIONAL",[91],"PHASE1","An open-label, non-randomized, 2-arm, 2-period fixed sequence phase 1 study to evaluate the potential inhibition of nitisinone on cytochrome P450 2C9, 2D6, and 2E1 and the organic anion transporters OAT1 and OAT3 in healthy volunteers",[94],"Drug Drug Interaction","COMPLETED","2017-08-09",{"date":98,"type":88},"2017-08-10",{"date":100,"type":88},"2017-03-28",{"date":102,"type":88},"2017-07-24",{"name":5,"class":6},1]