Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects
Tafenoquine is in development as a single-dose treatment for relapse prevention in individuals with Plasmodium vivax malaria. Tafenoquine must be coadministered with a blood schizonticide, either chloroquine or artemisinin-based combination therapy (ACT). This open-label, randomized, parallel-group...
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| creator | Green, Justin A Mohamed, Khadeeja Goyal, Navin Bouhired, Samia Hussaini, Azra Jones, Siôn W Koh, Gavin C K W Kostov, Ivan Taylor, Maxine Wolstenholm, Allen Duparc, Stephan |
| description | Tafenoquine is in development as a single-dose treatment for relapse prevention in individuals with Plasmodium vivax malaria. Tafenoquine must be coadministered with a blood schizonticide, either chloroquine or artemisinin-based combination therapy (ACT). This open-label, randomized, parallel-group study evaluated potential drug interactions between tafenoquine and two ACTs: dihydroartemisinin-piperaquine and artemether-lumefantrine. Healthy volunteers of either sex aged 18 to 65 years without glucose-6-phosphate dehydrogenase deficiency were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for 36 to |
| doi_str_mv | 10.1128/AAC.01588-16 |
| format | Article |
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) comparisons of tafenoquine plus ACT versus tafenoquine or ACT. All subjects receiving dihydroartemisinin-piperaquine experienced QTc prolongation (a known risk with this drug), but tafenoquine coadministration had no clinically relevant additional effect. Tafenoquine coadministration had no clinically relevant effects on dihydroartemisinin, piperaquine, artemether, or lumefantrine pharmacokinetics. Dihydroartemisinin-piperaquine coadministration increased the tafenoquine C
by 38% (90% confidence interval, 25 to 52%), the AUC from time zero to infinity (AUC
) by 12% (1 to 26%), and the half-life (t
) by 29% (19 to 40%), with no effect on the AUC from time zero to the time of the last nonzero concentration (AUC
). Artemether-lumefantrine coadministration had no effect on tafenoquine pharmacokinetics. Tafenoquine can be coadministered with dihydroartemisinin-piperaquine or artemether-lumefantrine without dose adjustment for any of these compounds. (This study has been registered at ClinicalTrials.gov under registration no. NCT02184637.).</description><identifier>ISSN: 0066-4804</identifier><identifier>EISSN: 1098-6596</identifier><identifier>DOI: 10.1128/AAC.01588-16</identifier><identifier>PMID: 27697758</identifier><language>eng</language><publisher>United States: American Society for Microbiology</publisher><subject>Adolescent ; Adult ; Aged ; Aminoquinolines ; Aminoquinolines - adverse effects ; Aminoquinolines - pharmacokinetics ; Antimalarials ; Antimalarials - adverse effects ; Antimalarials - pharmacokinetics ; Artemisinins ; Artemisinins - adverse effects ; Artemisinins - pharmacokinetics ; Clinical Therapeutics ; Drug Interactions ; Drug Therapy, Combination ; Ethanolamines ; Ethanolamines - adverse effects ; Ethanolamines - pharmacokinetics ; Female ; Fluorenes ; Fluorenes - adverse effects ; Fluorenes - pharmacokinetics ; Half-Life ; Healthy Volunteers ; Humans ; Malaria, Vivax ; Malaria, Vivax - drug therapy ; Male ; Middle Aged ; Plasmodium vivax - drug effects ; Quinolines ; Quinolines - adverse effects ; Quinolines - pharmacokinetics ; Young Adult</subject><ispartof>Antimicrobial agents and chemotherapy, 2016-12, Vol.60 (12), p.7321-7332</ispartof><rights>Copyright © 2016 Green et al.</rights><rights>Copyright © 2016 Green et al. 2016 Green et al.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a418t-fea1e0c27950a7a8c5035a05cc34c2a0460cb1294721a16b8b29405f5840d95c3</citedby><cites>FETCH-LOGICAL-a418t-fea1e0c27950a7a8c5035a05cc34c2a0460cb1294721a16b8b29405f5840d95c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5119013/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5119013/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27697758$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Green, Justin A</creatorcontrib><creatorcontrib>Mohamed, Khadeeja</creatorcontrib><creatorcontrib>Goyal, Navin</creatorcontrib><creatorcontrib>Bouhired, Samia</creatorcontrib><creatorcontrib>Hussaini, Azra</creatorcontrib><creatorcontrib>Jones, Siôn W</creatorcontrib><creatorcontrib>Koh, Gavin C K W</creatorcontrib><creatorcontrib>Kostov, Ivan</creatorcontrib><creatorcontrib>Taylor, Maxine</creatorcontrib><creatorcontrib>Wolstenholm, Allen</creatorcontrib><creatorcontrib>Duparc, Stephan</creatorcontrib><title>Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects</title><title>Antimicrobial agents and chemotherapy</title><addtitle>Antimicrob Agents Chemother</addtitle><addtitle>Antimicrob Agents Chemother</addtitle><description>Tafenoquine is in development as a single-dose treatment for relapse prevention in individuals with Plasmodium vivax malaria. Tafenoquine must be coadministered with a blood schizonticide, either chloroquine or artemisinin-based combination therapy (ACT). This open-label, randomized, parallel-group study evaluated potential drug interactions between tafenoquine and two ACTs: dihydroartemisinin-piperaquine and artemether-lumefantrine. Healthy volunteers of either sex aged 18 to 65 years without glucose-6-phosphate dehydrogenase deficiency were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for 36 to <75 kg of body weight and 160 mg/1,280 mg for ≥75 to 100 kg of body weight), or plus artemether-lumefantrine (80 mg/480 mg) in two doses 8 h apart on day 1 and then twice daily on days 2 and 3, or each drug alone. The pharmacokinetic parameters of tafenoquine, piperaquine, lumefantrine, artemether, and dihydroartemisinin were determined by using noncompartmental methods. Point estimates and 90% confidence intervals were calculated for area under the concentration-time curve (AUC) and maximum observed plasma concentration (C
) comparisons of tafenoquine plus ACT versus tafenoquine or ACT. All subjects receiving dihydroartemisinin-piperaquine experienced QTc prolongation (a known risk with this drug), but tafenoquine coadministration had no clinically relevant additional effect. Tafenoquine coadministration had no clinically relevant effects on dihydroartemisinin, piperaquine, artemether, or lumefantrine pharmacokinetics. Dihydroartemisinin-piperaquine coadministration increased the tafenoquine C
by 38% (90% confidence interval, 25 to 52%), the AUC from time zero to infinity (AUC
) by 12% (1 to 26%), and the half-life (t
) by 29% (19 to 40%), with no effect on the AUC from time zero to the time of the last nonzero concentration (AUC
). Artemether-lumefantrine coadministration had no effect on tafenoquine pharmacokinetics. Tafenoquine can be coadministered with dihydroartemisinin-piperaquine or artemether-lumefantrine without dose adjustment for any of these compounds. (This study has been registered at ClinicalTrials.gov under registration no. NCT02184637.).</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aminoquinolines</subject><subject>Aminoquinolines - adverse effects</subject><subject>Aminoquinolines - pharmacokinetics</subject><subject>Antimalarials</subject><subject>Antimalarials - adverse effects</subject><subject>Antimalarials - pharmacokinetics</subject><subject>Artemisinins</subject><subject>Artemisinins - adverse effects</subject><subject>Artemisinins - pharmacokinetics</subject><subject>Clinical Therapeutics</subject><subject>Drug Interactions</subject><subject>Drug Therapy, Combination</subject><subject>Ethanolamines</subject><subject>Ethanolamines - adverse effects</subject><subject>Ethanolamines - pharmacokinetics</subject><subject>Female</subject><subject>Fluorenes</subject><subject>Fluorenes - adverse effects</subject><subject>Fluorenes - pharmacokinetics</subject><subject>Half-Life</subject><subject>Healthy Volunteers</subject><subject>Humans</subject><subject>Malaria, Vivax</subject><subject>Malaria, Vivax - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Plasmodium vivax - drug effects</subject><subject>Quinolines</subject><subject>Quinolines - adverse effects</subject><subject>Quinolines - pharmacokinetics</subject><subject>Young Adult</subject><issn>0066-4804</issn><issn>1098-6596</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU9v1DAQxS0Eokvhxhn5ikSKncSOc0GKlj-ttBKVKGdr4kyIl4292E7RfoN-7HpZqODAaWb0fvM0o0fIS84uOC_V265bXzAulCq4fERWnLWqkKKVj8mKMSmLWrH6jDyLccvyLFr2lJyVjWybRqgVubueIMxg_HfrMFlDr1zCACZZ7yLtMf1EdPQGRnT-x5IZCm6g7-10GIKHkHC20Trrimu7z3snxAfaHSVME4Zis8w4gkvhKFlHLxF2aTrQblh2iX5Z-i2aFJ-TJyPsIr74Xc_J148fbtaXxebzp6t1tymg5ioVIwJHZsqmFQwaUEawSgATxlS1KYHVkpmel23dlBy47FWfeyZGoWo2tMJU5-TdyXe_9DMOBvNhsNP7YGcIB-3B6n8VZyf9zd9qwXnLeJUN3pwMTPAxBhwfdjnTx0R0TkT_SkRzmfHXJxziXOqtX4LL7_2PffX3bQ_Gf-Kq7gH1H5e2</recordid><startdate>20161201</startdate><enddate>20161201</enddate><creator>Green, Justin A</creator><creator>Mohamed, Khadeeja</creator><creator>Goyal, Navin</creator><creator>Bouhired, Samia</creator><creator>Hussaini, Azra</creator><creator>Jones, Siôn W</creator><creator>Koh, Gavin C K W</creator><creator>Kostov, Ivan</creator><creator>Taylor, Maxine</creator><creator>Wolstenholm, Allen</creator><creator>Duparc, Stephan</creator><general>American Society for Microbiology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20161201</creationdate><title>Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects</title><author>Green, Justin A ; Mohamed, Khadeeja ; Goyal, Navin ; Bouhired, Samia ; Hussaini, Azra ; Jones, Siôn W ; Koh, Gavin C K W ; Kostov, Ivan ; Taylor, Maxine ; Wolstenholm, Allen ; Duparc, Stephan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a418t-fea1e0c27950a7a8c5035a05cc34c2a0460cb1294721a16b8b29405f5840d95c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aminoquinolines</topic><topic>Aminoquinolines - adverse effects</topic><topic>Aminoquinolines - pharmacokinetics</topic><topic>Antimalarials</topic><topic>Antimalarials - adverse effects</topic><topic>Antimalarials - pharmacokinetics</topic><topic>Artemisinins</topic><topic>Artemisinins - adverse effects</topic><topic>Artemisinins - pharmacokinetics</topic><topic>Clinical Therapeutics</topic><topic>Drug Interactions</topic><topic>Drug Therapy, Combination</topic><topic>Ethanolamines</topic><topic>Ethanolamines - adverse effects</topic><topic>Ethanolamines - pharmacokinetics</topic><topic>Female</topic><topic>Fluorenes</topic><topic>Fluorenes - adverse effects</topic><topic>Fluorenes - pharmacokinetics</topic><topic>Half-Life</topic><topic>Healthy Volunteers</topic><topic>Humans</topic><topic>Malaria, Vivax</topic><topic>Malaria, Vivax - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Plasmodium vivax - drug effects</topic><topic>Quinolines</topic><topic>Quinolines - adverse effects</topic><topic>Quinolines - pharmacokinetics</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Green, Justin A</creatorcontrib><creatorcontrib>Mohamed, Khadeeja</creatorcontrib><creatorcontrib>Goyal, Navin</creatorcontrib><creatorcontrib>Bouhired, Samia</creatorcontrib><creatorcontrib>Hussaini, Azra</creatorcontrib><creatorcontrib>Jones, Siôn W</creatorcontrib><creatorcontrib>Koh, Gavin C K W</creatorcontrib><creatorcontrib>Kostov, Ivan</creatorcontrib><creatorcontrib>Taylor, Maxine</creatorcontrib><creatorcontrib>Wolstenholm, Allen</creatorcontrib><creatorcontrib>Duparc, Stephan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Antimicrobial agents and chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Green, Justin A</au><au>Mohamed, Khadeeja</au><au>Goyal, Navin</au><au>Bouhired, Samia</au><au>Hussaini, Azra</au><au>Jones, Siôn W</au><au>Koh, Gavin C K W</au><au>Kostov, Ivan</au><au>Taylor, Maxine</au><au>Wolstenholm, Allen</au><au>Duparc, Stephan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects</atitle><jtitle>Antimicrobial agents and chemotherapy</jtitle><stitle>Antimicrob Agents Chemother</stitle><addtitle>Antimicrob Agents Chemother</addtitle><date>2016-12-01</date><risdate>2016</risdate><volume>60</volume><issue>12</issue><spage>7321</spage><epage>7332</epage><pages>7321-7332</pages><issn>0066-4804</issn><eissn>1098-6596</eissn><abstract>Tafenoquine is in development as a single-dose treatment for relapse prevention in individuals with Plasmodium vivax malaria. Tafenoquine must be coadministered with a blood schizonticide, either chloroquine or artemisinin-based combination therapy (ACT). This open-label, randomized, parallel-group study evaluated potential drug interactions between tafenoquine and two ACTs: dihydroartemisinin-piperaquine and artemether-lumefantrine. Healthy volunteers of either sex aged 18 to 65 years without glucose-6-phosphate dehydrogenase deficiency were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for 36 to <75 kg of body weight and 160 mg/1,280 mg for ≥75 to 100 kg of body weight), or plus artemether-lumefantrine (80 mg/480 mg) in two doses 8 h apart on day 1 and then twice daily on days 2 and 3, or each drug alone. The pharmacokinetic parameters of tafenoquine, piperaquine, lumefantrine, artemether, and dihydroartemisinin were determined by using noncompartmental methods. Point estimates and 90% confidence intervals were calculated for area under the concentration-time curve (AUC) and maximum observed plasma concentration (C
) comparisons of tafenoquine plus ACT versus tafenoquine or ACT. All subjects receiving dihydroartemisinin-piperaquine experienced QTc prolongation (a known risk with this drug), but tafenoquine coadministration had no clinically relevant additional effect. Tafenoquine coadministration had no clinically relevant effects on dihydroartemisinin, piperaquine, artemether, or lumefantrine pharmacokinetics. Dihydroartemisinin-piperaquine coadministration increased the tafenoquine C
by 38% (90% confidence interval, 25 to 52%), the AUC from time zero to infinity (AUC
) by 12% (1 to 26%), and the half-life (t
) by 29% (19 to 40%), with no effect on the AUC from time zero to the time of the last nonzero concentration (AUC
). Artemether-lumefantrine coadministration had no effect on tafenoquine pharmacokinetics. Tafenoquine can be coadministered with dihydroartemisinin-piperaquine or artemether-lumefantrine without dose adjustment for any of these compounds. (This study has been registered at ClinicalTrials.gov under registration no. NCT02184637.).</abstract><cop>United States</cop><pub>American Society for Microbiology</pub><pmid>27697758</pmid><doi>10.1128/AAC.01588-16</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0066-4804 |
| ispartof | Antimicrobial agents and chemotherapy, 2016-12, Vol.60 (12), p.7321-7332 |
| issn | 0066-4804 1098-6596 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5119013 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | Adolescent Adult Aged Aminoquinolines Aminoquinolines - adverse effects Aminoquinolines - pharmacokinetics Antimalarials Antimalarials - adverse effects Antimalarials - pharmacokinetics Artemisinins Artemisinins - adverse effects Artemisinins - pharmacokinetics Clinical Therapeutics Drug Interactions Drug Therapy, Combination Ethanolamines Ethanolamines - adverse effects Ethanolamines - pharmacokinetics Female Fluorenes Fluorenes - adverse effects Fluorenes - pharmacokinetics Half-Life Healthy Volunteers Humans Malaria, Vivax Malaria, Vivax - drug therapy Male Middle Aged Plasmodium vivax - drug effects Quinolines Quinolines - adverse effects Quinolines - pharmacokinetics Young Adult |
| title | Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects |
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