{"id":"https://openalex.org/W2189232079","doi":null,"title":"Phase I/pharmacodynamic study of N-acetylcysteine/oltipraz in smokers: early termination due to excessive toxicity.","display_name":"Phase I/pharmacodynamic study of N-acetylcysteine/oltipraz in smokers: early termination due to excessive toxicity.","publication_year":2001,"publication_date":"2001-03-01","ids":{"openalex":"https://openalex.org/W2189232079","mag":"2189232079","pmid":"https://pubmed.ncbi.nlm.nih.gov/11303598"},"language":"en","primary_location":{"id":"pmid:11303598","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/11303598","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":"Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology","raw_type":"Clinical Trial"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["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/A5088972279","display_name":"Lakshmi Pendyala","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1292894508","display_name":"Roswell Park Comprehensive Cancer Center","ror":"https://ror.org/0499dwk57","country_code":"US","type":"facility","lineage":["https://openalex.org/I1292894508"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"L Pendyala","raw_affiliation_strings":["Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York 14263, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York 14263, USA","institution_ids":["https://openalex.org/I1292894508"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000104295","display_name":"Gary N. Schwartz","orcid":"https://orcid.org/0000-0003-2537-9531","observed_orcids":["https://orcid.org/0000-0003-2537-9531"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"G Schwartz","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5030762997","display_name":"Wanda Bolanowska-Higdon","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"W Bolanowska-Higdon","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032303399","display_name":"Sandra Hitt","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"S Hitt","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5066237652","display_name":"Joseph Zdanowicz","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"J Zdanowicz","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":null,"display_name":"M Murphy","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"M Murphy","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5111937082","display_name":"David D. Lawrence","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"D Lawrence","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5111674028","display_name":"Patrick J. Creaven","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"P J Creaven","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.8662,"has_fulltext":false,"cited_by_count":30,"citation_normalized_percentile":{"value":0.6745487,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":87,"max":96},"biblio":{"volume":"10","issue":"3","first_page":"269","last_page":"72"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12187","display_name":"Glutathione Transferases and Polymorphisms","score":0.5619999766349792,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T12187","display_name":"Glutathione Transferases and Polymorphisms","score":0.5619999766349792,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10375","display_name":"Pharmacogenetics and Drug Metabolism","score":0.26980000734329224,"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/T11465","display_name":"Drug-Induced Hepatotoxicity and Protection","score":0.06610000133514404,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/n-acetylcysteine","display_name":"N-acetylcysteine","score":0.9990000128746033},{"id":"https://openalex.org/keywords/oltipraz","display_name":"oltipraz","score":0.7860000133514404},{"id":"https://openalex.org/keywords/smokers","display_name":"smokers","score":0.7379999756813049},{"id":"https://openalex.org/keywords/toxicity","display_name":"toxicity","score":0.4830000102519989},{"id":"https://openalex.org/keywords/glutathione","display_name":"glutathione","score":0.8700000047683716},{"id":"https://openalex.org/keywords/gamma-glutamylcysteine-synthetase","display_name":"gamma-glutamylcysteine synthetase","score":0.9769999980926514},{"id":"https://openalex.org/keywords/glutathione-s-transferase","display_name":"glutathione S-transferase","score":0.9070000052452087},{"id":"https://openalex.org/keywords/nad-p-h-quinone-oxidoreductase","display_name":"NAD(P)H:quinone oxidoreductase","score":0.9779999852180481},{"id":"https://openalex.org/keywords/chemoprevention","display_name":"chemoprevention","score":0.7369999885559082},{"id":"https://openalex.org/keywords/lymphocytes","display_name":"lymphocytes","score":0.37299999594688416}],"concepts":[{"id":"https://openalex.org/C538909803","wikidata":"https://www.wikidata.org/wiki/Q116907","display_name":"Glutathione","level":3,"score":0.7505024075508118},{"id":"https://openalex.org/C29730261","wikidata":"https://www.wikidata.org/wiki/Q274160","display_name":"Toxicity","level":2,"score":0.691081166267395},{"id":"https://openalex.org/C111113717","wikidata":"https://www.wikidata.org/wiki/Q725307","display_name":"Pharmacodynamics","level":3,"score":0.6398265957832336},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.6365711092948914},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.4860439896583557},{"id":"https://openalex.org/C2777847592","wikidata":"https://www.wikidata.org/wiki/Q375613","display_name":"Acetylcysteine","level":3,"score":0.4820319414138794},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4547944664955139},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.42487475275993347},{"id":"https://openalex.org/C2778004101","wikidata":"https://www.wikidata.org/wiki/Q133948","display_name":"Antioxidant","level":2,"score":0.3473338782787323},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.32410484552383423},{"id":"https://openalex.org/C55493867","wikidata":"https://www.wikidata.org/wiki/Q7094","display_name":"Biochemistry","level":1,"score":0.22639641165733337},{"id":"https://openalex.org/C181199279","wikidata":"https://www.wikidata.org/wiki/Q8047","display_name":"Enzyme","level":2,"score":0.20868229866027832}],"mesh":[{"descriptor_ui":"D000111","descriptor_name":"Acetylcysteine","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D000111","descriptor_name":"Acetylcysteine","qualifier_ui":"Q000633","qualifier_name":"toxicity","is_major_topic":true},{"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":"D004305","descriptor_name":"Dose-Response Relationship, Drug","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004334","descriptor_name":"Drug Administration Schedule","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004359","descriptor_name":"Drug Therapy, Combination","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005221","descriptor_name":"Fatigue","qualifier_ui":"Q000139","qualifier_name":"chemically induced","is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005767","descriptor_name":"Gastrointestinal Diseases","qualifier_ui":"Q000139","qualifier_name":"chemically induced","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"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":"D011719","descriptor_name":"Pyrazines","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D011719","descriptor_name":"Pyrazines","qualifier_ui":"Q000633","qualifier_name":"toxicity","is_major_topic":true},{"descriptor_ui":"D012016","descriptor_name":"Reference Values","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012907","descriptor_name":"Smoking","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013871","descriptor_name":"Thiones","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013876","descriptor_name":"Thiophenes","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018570","descriptor_name":"Risk Assessment","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"pmid:11303598","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/11303598","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":"Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology","raw_type":"Clinical Trial"},{"id":"mag:2189232079","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/11303598","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":null,"is_accepted":false,"is_published":false,"raw_source_name":"PubMed","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"score":1.0,"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":[{"id":"https://openalex.org/G1007632892","display_name":"PHASE I SINGLE &MULTIPLE-DOSE PHARMACOKINETIC","funder_award_id":"n01cn055123-004","funder_id":"https://openalex.org/F4320332161","funder_display_name":"National Institutes of Health"}],"funders":[{"id":"https://openalex.org/F4320332161","display_name":"National Institutes of Health","ror":"https://ror.org/01cwqze88"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":14,"referenced_works":["https://openalex.org/W1536923222","https://openalex.org/W1944393794","https://openalex.org/W1986093957","https://openalex.org/W2009412318","https://openalex.org/W2029079353","https://openalex.org/W2035925347","https://openalex.org/W2045061052","https://openalex.org/W2061757494","https://openalex.org/W2067576161","https://openalex.org/W2083996851","https://openalex.org/W2088617625","https://openalex.org/W2115558240","https://openalex.org/W2165642246","https://openalex.org/W2170877675"],"related_works":["https://openalex.org/W1944393794","https://openalex.org/W4390894166","https://openalex.org/W2117465918","https://openalex.org/W2165541480","https://openalex.org/W2522682733","https://openalex.org/W2900829707","https://openalex.org/W2047689870","https://openalex.org/W2412995761","https://openalex.org/W3012588372","https://openalex.org/W2289081559"],"abstract_inverted_index":{"An":[0],"N-acetylcysteine":[1],"(NAC)/oltipraz":[2],"(OLZ)":[3],"combination":[4],"was":[5,36,47,79,144,205],"studied":[6],"in":[7,146,149,158,185,200,224],"healthy":[8],"volunteer":[9],"smokers":[10],"who":[11],"received":[12],"daily":[13],"NAC":[14],"(1200":[15],"mg/day)":[16],"and":[17,51,73,97,111,120,132,134,148,169,172,181,189],"were":[18,106,117,160,232],"randomized":[19],"to":[20,48,87,243],"weekly":[21],"placebo":[22],"(Arm":[23,28,33,67,94],"A),":[24],"OLZ":[25,127],"200":[26],"mg":[27,32],"B),":[29],"or":[30,214,220],"400":[31],"C).":[34],"Treatment":[35],"for":[37,249],"12":[38,89,133],"weeks":[39,90,129,136],"with":[40],"follow-up":[41],"at":[42,128,196,218,251],"16":[43],"weeks.":[44],"The":[45,101],"objective":[46],"study":[49,78],"toxicity":[50],"the":[52,77,124,138,161,173,190,206,252],"modulation":[53],"of":[54,60,62,82,91,126,140,164,176,192,208,226],"pharmacodynamic":[55],"end":[56,115,139,155,230,240],"points.":[57],"After":[58],"treatment":[59],"19":[61,227],"a":[63,212],"planned":[64],"60":[65],"subjects,":[66],"A,":[68,95],"six;":[69],"Arm":[70,74,98],"B,":[71],"four;":[72],"C,":[75,99],"nine),":[76],"closed":[80],"because":[81],"toxicity.":[83],"Eight":[84],"subjects":[85],"failed":[86],"complete":[88],"drug":[92],"administration,":[93],"two,":[96],"six).":[100],"most":[102],"frequent":[103],"side":[104],"effects":[105],"gastrointestinal,":[107],"fatigue,":[108],"conjunctival":[109],"irritation,":[110],"skin":[112],"rash.":[113],"Pharmacodynamic":[114],"points":[116,156,199,223,231,241],"measured":[118,145,157],"pretreatment":[119],"48":[121],"h":[122],"after":[123,137],"dose":[125],"1,":[130],"5,":[131],"4":[135],"treatment.":[141],"Glutathione":[142],"(GSH)":[143],"plasma":[147],"peripheral":[150],"blood":[151],"lymphocytes":[152],"(PBLs).":[153],"Other":[154,229],"PBLs":[159],"enzyme":[162],"activities":[163],"total":[165],"glutathione-S-transferase":[166],"(GST),":[167],"GSTpi,":[168,180],"NAD(P)H:quinone":[170,182],"oxidoreductase;":[171],"mRNA":[174,191,207],"expression":[175],"gamma-glutamylcysteine":[177],"synthetase":[178],"gammaGCS),":[179],"oxidoreductase.":[183],"GSH":[184,244],"PBLs,":[186],"GST":[187],"(total),":[188],"gammaGCS":[193],"showed":[194,211],"increases":[195],"some":[197,201,239],"time":[198,222],"subjects.":[202,228],"Most":[203],"consistent":[204],"gammaGCS,":[209],"which":[210],">":[213],"=":[215],"30%":[216],"increase":[217],"one":[219],"more":[221],"11":[225],"unchanged.":[233],"We":[234],"concluded":[235],"that":[236],"NAC/OLZ":[237],"modulates":[238],"related":[242],"but":[245],"is":[246],"too":[247],"toxic":[248],"chemoprevention":[250],"doses":[253],"used.":[254]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":1},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":1},{"year":2016,"cited_by_count":2},{"year":2015,"cited_by_count":1},{"year":2013,"cited_by_count":1},{"year":2012,"cited_by_count":2}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}
