{"id":"https://openalex.org/W4402850872","doi":"https://doi.org/10.1002/cpdd.1469","title":"Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites","display_name":"Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites","publication_year":2024,"publication_date":"2024-09-25","ids":{"openalex":"https://openalex.org/W4402850872","doi":"https://doi.org/10.1002/cpdd.1469","pmid":"https://pubmed.ncbi.nlm.nih.gov/39318306"},"language":"en","primary_location":{"id":"doi:10.1002/cpdd.1469","doi":"https://doi.org/10.1002/cpdd.1469","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpdd.1469","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.1469","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":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","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":true,"oa_status":"hybrid","oa_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.1469","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","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\u00ae  Schotten Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"clinphase\u00ae  Schotten Germany","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5081820264","display_name":"Susanne Bonsmann","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":"Susanne Bonsmann","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/A5033019979","display_name":"J\u00f6rg Pausch","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":"J\u00f6rg Pausch","raw_affiliation_strings":["Affiliation at time of the studies: Aicuris Anti\u2010infective Cures AG  Wuppertal Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Affiliation at time of the studies: Aicuris Anti\u2010infective Cures AG  Wuppertal Germany","institution_ids":["https://openalex.org/I4210157949"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5034137042","display_name":"Melanie E Sumner","orcid":"https://orcid.org/0009-0009-0205-4970","observed_orcids":["https://orcid.org/0009-0009-0205-4970"]},"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":"Melanie Sumner","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/A5005777715","display_name":"Alexander Birkmann","orcid":"https://orcid.org/0000-0001-5670-4814","observed_orcids":["https://orcid.org/0000-0001-5670-4814"]},"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":"Alexander Birkmann","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":"middle","author":{"id":"https://openalex.org/A5114013451","display_name":"Atef Halabi","orcid":"https://orcid.org/0000-0001-9896-6097","observed_orcids":["https://orcid.org/0000-0001-9896-6097"]},"institutions":[{"id":"https://openalex.org/I4210103903","display_name":"Clinical Research Services","ror":"https://ror.org/01c127k53","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210103903"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Atef Halabi","raw_affiliation_strings":["CRS Clinical Research Services Kiel GmbH  Kiel Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CRS Clinical Research Services Kiel GmbH  Kiel Germany","institution_ids":["https://openalex.org/I4210103903"]}]},{"author_position":"last","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"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5020698210"],"corresponding_institution_ids":["https://openalex.org/I4210157949"],"apc_list":{"value":3620,"currency":"USD","value_usd":3620},"apc_paid":{"value":3620,"currency":"USD","value_usd":3620},"fwci":0.2411,"has_fulltext":true,"cited_by_count":1,"citation_normalized_percentile":{"value":0.4699448,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":93},"biblio":{"volume":"13","issue":"11","first_page":"1198","last_page":"1211"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10375","display_name":"Pharmacogenetics and Drug Metabolism","score":0.5928000211715698,"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"}},"topics":[{"id":"https://openalex.org/T10375","display_name":"Pharmacogenetics and Drug Metabolism","score":0.5928000211715698,"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/T11036","display_name":"Antibiotics Pharmacokinetics and Efficacy","score":0.0812000036239624,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology (medical)"},"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/T12547","display_name":"Pharmaceutical studies and practices","score":0.05909999832510948,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"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/pritelivir","display_name":"pritelivir","score":0.996999979019165},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.8299999833106995},{"id":"https://openalex.org/keywords/renal-dysfunction","display_name":"renal dysfunction","score":0.9980000257492065},{"id":"https://openalex.org/keywords/liver-dysfunction","display_name":"liver dysfunction","score":0.996999979019165},{"id":"https://openalex.org/keywords/drug-metabolites","display_name":"drug metabolites","score":0.8809999823570251},{"id":"https://openalex.org/keywords/plasma-protein-binding","display_name":"plasma protein binding","score":0.9279999732971191},{"id":"https://openalex.org/keywords/free-fraction","display_name":"free fraction","score":0.6520000100135803},{"id":"https://openalex.org/keywords/drug-exposure","display_name":"drug exposure","score":0.5730000138282776},{"id":"https://openalex.org/keywords/hiv-protease-inhibitors","display_name":"HIV protease inhibitors","score":0.46299999952316284}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9006301164627075},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.6940034031867981},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.5909414887428284},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.44054660201072693},{"id":"https://openalex.org/C126894567","wikidata":"https://www.wikidata.org/wiki/Q105650","display_name":"Urology","level":1,"score":0.32087308168411255}],"mesh":[{"descriptor_ui":"D000284","descriptor_name":"Administration, Oral","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000368","descriptor_name":"Aged","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":"D008107","descriptor_name":"Liver Diseases","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011485","descriptor_name":"Protein Binding","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012720","descriptor_name":"Severity of Illness Index","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013449","descriptor_name":"Sulfonamides","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D013449","descriptor_name":"Sulfonamides","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D013449","descriptor_name":"Sulfonamides","qualifier_ui":"Q000097","qualifier_name":"blood","is_major_topic":false},{"descriptor_ui":"D013449","descriptor_name":"Sulfonamides","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D019540","descriptor_name":"Area Under Curve","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D051437","descriptor_name":"Renal Insufficiency","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":true},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1002/cpdd.1469","doi":"https://doi.org/10.1002/cpdd.1469","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpdd.1469","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.1469","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":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology in Drug Development","raw_type":"journal-article"},{"id":"pmid:39318306","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/39318306","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":"Journal Article"}],"best_oa_location":{"id":"doi:10.1002/cpdd.1469","doi":"https://doi.org/10.1002/cpdd.1469","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpdd.1469","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.1469","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":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology in Drug Development","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9940000176429749}],"study_designs":[{"id":"https://openalex.org/study-designs/clinical-trial","display_name":"Clinical Trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4402850872.pdf","grobid_xml":"https://content.openalex.org/works/W4402850872.grobid-xml"},"referenced_works_count":18,"referenced_works":["https://openalex.org/W1985138005","https://openalex.org/W1993701927","https://openalex.org/W2029171849","https://openalex.org/W2029925693","https://openalex.org/W2060123467","https://openalex.org/W2073743033","https://openalex.org/W2110002916","https://openalex.org/W2148365504","https://openalex.org/W2155727299","https://openalex.org/W2155965977","https://openalex.org/W2246750959","https://openalex.org/W2562795102","https://openalex.org/W3160681262","https://openalex.org/W4298088915","https://openalex.org/W4302760248","https://openalex.org/W4322758576","https://openalex.org/W4390668990","https://openalex.org/W4396958061"],"related_works":["https://openalex.org/W3037821464","https://openalex.org/W2269624746","https://openalex.org/W4395011252","https://openalex.org/W2053879286","https://openalex.org/W1956410366","https://openalex.org/W2152991448","https://openalex.org/W7142192055","https://openalex.org/W2161595437","https://openalex.org/W2411255103","https://openalex.org/W1983822054"],"abstract_inverted_index":{"Abstract":[0],"Two":[1],"trials":[2,45],"were":[3],"performed":[4],"to":[5,102,170],"evaluate":[6],"the":[7,15,35,81,95,125,143],"effect":[8,79,179],"of":[9,17,51,59,62,83,165,180],"renal":[10,23,67,89,122,166,202],"and":[11,19,31,65,69,119,154,188,193,199],"hepatic":[12,36,71,134,182,204],"impairment":[13,24,37,68,72,167,183],"on":[14,80],"pharmacokinetics":[16,82],"pritelivir":[18,91,138],"its":[20],"metabolites.":[21],"The":[22],"trial":[25,38],"included":[26,39],"subjects":[27,40,86,118,131,198,200],"with":[28,41,87,109,121,132,162,174,201],"mild,":[29],"moderate,":[30],"severe":[32,88],"impairment,":[33,90,123,135],"while":[34,124],"moderate":[42,66,70,133,169,181],"impairment.":[43,176,205],"Both":[44],"recruited":[46],"a":[47,55,76],"matched":[48],"control":[49],"group":[50],"healthy":[52,197],"subjects.":[53],"Following":[54],"single":[56],"oral":[57],"dose":[58],"100":[60],"mg":[61],"pritelivir,":[63],"mild":[64,175],"did":[73],"not":[74,173],"have":[75],"clinically":[77],"relevant":[78],"pritelivir.":[84],"In":[85],"exposure":[92,139,159],"(area":[93],"under":[94],"plasma":[96,112],"concentration\u2010time":[97],"curve":[98],"from":[99],"time":[100],"0":[101],"infinity":[103],"(AUC0\u2010inf)":[104],"was":[105,115,128,160,184,191],"57%":[106],"higher":[107,129,158],"compared":[108],"controls.":[110],"Pritelivir":[111,190],"protein":[113],"binding":[114],"similar":[116],"in":[117,130,196],"controls":[120],"free":[126],"fraction":[127],"increasing":[136,163],"unbound":[137],"by":[140],"23%.":[141],"For":[142],"metabolites":[144],"pyridinyl":[145],"phenyl":[146],"acetic":[147],"acid":[148],"(PPA),":[149],"amino":[150],"thiazole":[151],"sulfonamide":[152],"(ATS),":[153],"PPA\u2010acyl":[155],"glucuronide,":[156],"generally":[157],"observed":[161,185],"degree":[164],"(ie,":[168],"severe),":[171],"but":[172],"A":[177],"modest":[178],"for":[186],"PPA":[187],"ATS.":[189],"safe":[192],"well":[194],"tolerated":[195],"or":[203]},"counts_by_year":[{"year":2025,"cited_by_count":1}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2024-09-26T00:00:00"}