{"id":"https://openalex.org/W3211258100","doi":"https://doi.org/10.1002/cpdd.1027","title":"Pharmacokinetics and Safety of Letermovir and Midazolam Coadministration in Healthy Subjects","display_name":"Pharmacokinetics and Safety of Letermovir and Midazolam Coadministration in Healthy Subjects","publication_year":2021,"publication_date":"2021-10-29","ids":{"openalex":"https://openalex.org/W3211258100","doi":"https://doi.org/10.1002/cpdd.1027","mag":"3211258100","pmid":"https://pubmed.ncbi.nlm.nih.gov/34714967"},"language":"en","primary_location":{"id":"doi:10.1002/cpdd.1027","doi":"https://doi.org/10.1002/cpdd.1027","is_oa":false,"landing_page_url":"https://doi.org/10.1002/cpdd.1027","pdf_url":null,"source":{"id":"https://openalex.org/S2764863641","display_name":"Clinical Pharmacology in Drug Development","issn_l":"2160-763X","issn":["2160-763X","2160-7648"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology in Drug Development","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5020698210","display_name":"Dirk Kropeit","orcid":"https://orcid.org/0000-0003-0356-2052","observed_orcids":["https://orcid.org/0000-0003-0356-2052"]},"institutions":[{"id":"https://openalex.org/I4210157949","display_name":"AiCuris (Germany)","ror":"https://ror.org/048jsd987","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210157949"]}],"countries":["DE"],"is_corresponding":true,"raw_author_name":"Dirk Kropeit","raw_affiliation_strings":["AiCuris Anti\u2010infective Cures AG  Wuppertal Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AiCuris Anti\u2010infective Cures AG  Wuppertal Germany","institution_ids":["https://openalex.org/I4210157949"]}]},{"author_position":"middle","author":{"id":null,"display_name":"David McCormick","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210157949","display_name":"AiCuris (Germany)","ror":"https://ror.org/048jsd987","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210157949"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"David McCormick","raw_affiliation_strings":["AiCuris Anti\u2010infective Cures AG  Wuppertal Germany","Current address: DMPK Solutions Ltd.  Nottingham Nottinghamshire UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AiCuris Anti\u2010infective Cures AG  Wuppertal Germany","institution_ids":["https://openalex.org/I4210157949"]},{"raw_affiliation_string":"Current address: DMPK Solutions Ltd.  Nottingham Nottinghamshire UK","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032138839","display_name":"Katharina Erb\u2010Zohar","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Katharina Erb\u2010Zohar","raw_affiliation_strings":["clinphase<sup>\u00ae</sup>  Schotten Germany","clinphase\u00ae  Schotten Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"clinphase<sup>\u00ae</sup>  Schotten Germany","institution_ids":[]},{"raw_affiliation_string":"clinphase\u00ae  Schotten Germany","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5027758364","display_name":"Hans\u2010Peter Stobernack","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210157949","display_name":"AiCuris (Germany)","ror":"https://ror.org/048jsd987","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210157949"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Hans\u2010Peter Stobernack","raw_affiliation_strings":["AiCuris Anti\u2010infective Cures AG  Wuppertal Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AiCuris Anti\u2010infective Cures AG  Wuppertal Germany","institution_ids":["https://openalex.org/I4210157949"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004728480","display_name":"Holger Zimmermann","orcid":"https://orcid.org/0000-0002-7919-4447","observed_orcids":["https://orcid.org/0000-0002-7919-4447"]},"institutions":[{"id":"https://openalex.org/I4210157949","display_name":"AiCuris (Germany)","ror":"https://ror.org/048jsd987","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210157949"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Holger Zimmermann","raw_affiliation_strings":["AiCuris Anti\u2010infective Cures AG  Wuppertal Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AiCuris Anti\u2010infective Cures AG  Wuppertal Germany","institution_ids":["https://openalex.org/I4210157949"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5004530281","display_name":"Helga R\u00fcbsamen\u2010Schaeff","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210157949","display_name":"AiCuris (Germany)","ror":"https://ror.org/048jsd987","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210157949"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Helga R\u00fcbsamen\u2010Schaeff","raw_affiliation_strings":["AiCuris Anti\u2010infective Cures AG  Wuppertal Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AiCuris Anti\u2010infective Cures AG  Wuppertal Germany","institution_ids":["https://openalex.org/I4210157949"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5020698210"],"corresponding_institution_ids":["https://openalex.org/I4210157949"],"apc_list":{"value":3300,"currency":"USD","value_usd":3300},"apc_paid":null,"fwci":2.004,"has_fulltext":false,"cited_by_count":12,"citation_normalized_percentile":{"value":0.86048146,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":87,"max":98},"biblio":{"volume":"11","issue":"1","first_page":"16","last_page":"24"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10981","display_name":"Cytomegalovirus and herpesvirus research","score":0.5557000041007996,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10981","display_name":"Cytomegalovirus and herpesvirus research","score":0.5557000041007996,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10375","display_name":"Pharmacogenetics and Drug Metabolism","score":0.4235999882221222,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10526","display_name":"HIV/AIDS drug development and treatment","score":0.001500000013038516,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/letermovir","display_name":"letermovir","score":1.0},{"id":"https://openalex.org/keywords/midazolam","display_name":"midazolam","score":0.9980000257492065},{"id":"https://openalex.org/keywords/cyp3a-inhibition","display_name":"CYP3A inhibition","score":0.9259999990463257},{"id":"https://openalex.org/keywords/drug-drug-interactions","display_name":"drug-drug interactions","score":0.8899999856948853},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.8610000014305115},{"id":"https://openalex.org/keywords/human-cytomegalovirus","display_name":"human cytomegalovirus","score":0.7889999747276306},{"id":"https://openalex.org/keywords/hematopoietic-stem-cell-transplantation","display_name":"hematopoietic stem cell transplantation","score":0.7170000076293945},{"id":"https://openalex.org/keywords/1-hydroxymidazolam","display_name":"1'-hydroxymidazolam","score":0.8759999871253967},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.48399999737739563},{"id":"https://openalex.org/keywords/tolerability","display_name":"tolerability","score":0.6890000104904175}],"concepts":[{"id":"https://openalex.org/C2778000748","wikidata":"https://www.wikidata.org/wiki/Q423071","display_name":"Midazolam","level":3,"score":0.9138354659080505},{"id":"https://openalex.org/C11824378","wikidata":"https://www.wikidata.org/wiki/Q5014970","display_name":"CYP3A","level":4,"score":0.8551349639892578},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.8186944723129272},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.6772816181182861},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.673163115978241},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.5703462958335876},{"id":"https://openalex.org/C3020079912","wikidata":"https://www.wikidata.org/wiki/Q3918988","display_name":"Plasma concentration","level":2,"score":0.452382355928421},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.2524675726890564},{"id":"https://openalex.org/C526171541","wikidata":"https://www.wikidata.org/wiki/Q407693","display_name":"Cytochrome P450","level":3,"score":0.2521269917488098},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.2357361614704132},{"id":"https://openalex.org/C62231903","wikidata":"https://www.wikidata.org/wiki/Q1057","display_name":"Metabolism","level":2,"score":0.05581623315811157},{"id":"https://openalex.org/C2776814716","wikidata":"https://www.wikidata.org/wiki/Q574801","display_name":"Sedation","level":2,"score":0.05372047424316406}],"mesh":[{"descriptor_ui":"D000085","descriptor_name":"Acetates","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004347","descriptor_name":"Drug Interactions","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008874","descriptor_name":"Midazolam","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D008874","descriptor_name":"Midazolam","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D008874","descriptor_name":"Midazolam","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D011799","descriptor_name":"Quinazolines","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D019540","descriptor_name":"Area Under Curve","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D064368","descriptor_name":"Healthy Volunteers","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1002/cpdd.1027","doi":"https://doi.org/10.1002/cpdd.1027","is_oa":false,"landing_page_url":"https://doi.org/10.1002/cpdd.1027","pdf_url":null,"source":{"id":"https://openalex.org/S2764863641","display_name":"Clinical Pharmacology in Drug Development","issn_l":"2160-763X","issn":["2160-763X","2160-7648"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology in Drug Development","raw_type":"journal-article"},{"id":"pmid:34714967","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/34714967","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical pharmacology in drug development","raw_type":"Clinical Trial, Phase I"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.98580002784729,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/clinical-trial","display_name":"Clinical Trial"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":33,"referenced_works":["https://openalex.org/W185309396","https://openalex.org/W337711649","https://openalex.org/W1533537097","https://openalex.org/W1891093822","https://openalex.org/W1974647054","https://openalex.org/W1986224353","https://openalex.org/W1996558200","https://openalex.org/W1999318002","https://openalex.org/W2035263876","https://openalex.org/W2046433603","https://openalex.org/W2082979826","https://openalex.org/W2096041737","https://openalex.org/W2109230548","https://openalex.org/W2116972576","https://openalex.org/W2147027267","https://openalex.org/W2165903332","https://openalex.org/W2185302064","https://openalex.org/W2317759605","https://openalex.org/W2764242421","https://openalex.org/W2771598353","https://openalex.org/W2790919647","https://openalex.org/W2808680764","https://openalex.org/W2937912175","https://openalex.org/W2948118452","https://openalex.org/W2949417789","https://openalex.org/W2955776600","https://openalex.org/W2977630397","https://openalex.org/W3009172927","https://openalex.org/W3037493873","https://openalex.org/W3045409620","https://openalex.org/W3131796522","https://openalex.org/W3217550101","https://openalex.org/W4313139150"],"related_works":["https://openalex.org/W2808680764","https://openalex.org/W4214848147","https://openalex.org/W3131796522","https://openalex.org/W4309277605","https://openalex.org/W2063517776","https://openalex.org/W2739476529","https://openalex.org/W2903255167","https://openalex.org/W4400683082","https://openalex.org/W3206751387","https://openalex.org/W4391014659"],"abstract_inverted_index":{"Letermovir":[0,75,200,217],"is":[1],"a":[2,29,51],"human":[3],"cytomegalovirus":[4],"(CMV)":[5],"terminase":[6],"inhibitor":[7],"for":[8,127,151,159],"the":[9,37,42,116,122,134,142,165,173,185],"prophylaxis":[10],"of":[11,39,91,178,187],"CMV":[12],"infection":[13],"and":[14,64,72,87,96,106,111,131,148,154,156,194],"disease":[15],"in":[16,50,184],"allogeneic":[17],"hematopoietic":[18],"stem-cell":[19],"transplant":[20],"recipients.":[21],"In":[22],"vitro":[23],"studies":[24],"have":[25],"identified":[26],"letermovir":[27,40,188],"as":[28],"potential":[30],"cytochrome":[31],"P450":[32],"(CYP)":[33],"3A":[34],"inhibitor.":[35],"Thus,":[36],"effect":[38],"on":[41,69,82,103,204],"CYP3A":[43,220],"isoenzyme-specific":[44],"probe":[45],"drug":[46],"midazolam":[47,68,92,98,160,179],"was":[48,80,146],"investigated":[49],"phase":[52],"1":[53,62,84,93],"trial.":[54,117],"Healthy":[55],"female":[56],"subjects":[57],"received":[58],"single-dose":[59],"intravenous":[60],"(IV;":[61],"mg)":[63,67],"oral":[65,97,152,195],"(2":[66],"days":[70,83,104,207],"-4":[71],"-2,":[73],"respectively.":[74,108],"240":[76],"mg":[77,94,100],"once":[78],"daily":[79],"administered":[81,102],"to":[85,141,172,180,209],"6,":[86,107],"further":[88],"single":[89],"doses":[90],"IV":[95,190],"2":[99],"were":[101,113,213],"4":[105],"Pharmacokinetics,":[109],"tolerability,":[110],"safety":[112],"monitored":[114],"throughout":[115],"Following":[118],"coadministration":[119],"with":[120],"letermovir,":[121],"least":[123],"square":[124],"means":[125],"ratio":[126,177],"maximum":[128],"plasma":[129,135,166],"concentration":[130,145,176],"area":[132,163],"under":[133,164],"concentration-time":[136,167],"curve":[137,168],"from":[138,169],"time":[139,170],"0":[140,171],"last":[143,174],"measurable":[144,175],"172.4%":[147],"225.3%,":[149],"respectively,":[150,158],"midazolam,":[153],"105.2%":[155],"146.6%,":[157],"IV.":[161],"The":[162],"1-hydroxymidazolam":[181],"increased":[182],"slightly":[183],"presence":[186],"following":[189],"(8.8-13.1;":[191],"49%":[192],"increase)":[193,198],"(3.3-5.3;":[196],"59%":[197],"midazolam.":[199],"reached":[201],"steady":[202],"state,":[203],"average,":[205],"by":[206],"5":[208],"6.":[210],"All":[211],"treatments":[212],"generally":[214],"well":[215],"tolerated.":[216],"demonstrated":[218],"moderate":[219],"inhibition.":[221]},"counts_by_year":[{"year":2024,"cited_by_count":5},{"year":2023,"cited_by_count":2},{"year":2022,"cited_by_count":3},{"year":2021,"cited_by_count":1}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2021-11-08T00:00:00"}
