Pharmacokinetic Evaluation of Emtricitabine in Combination With Other Nucleoside Antivirals in Healthy Volunteers
Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once‐daily drug in combination with other antiretroviral agents for the treatment of HIV infection. Several phase I studies were conducted in healthy volunteers over the course of clinical development to evaluate whet...
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| Veröffentlicht in: | Journal of clinical pharmacology 2007-07, Vol.47 (7), p.877-889 |
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| creator | Zong, Jian Chittick, Gregory E. Wang, Laurene H. Hui, James Begley, John A. Blum, M. Robert |
| description | Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once‐daily drug in combination with other antiretroviral agents for the treatment of HIV infection. Several phase I studies were conducted in healthy volunteers over the course of clinical development to evaluate whether pharmacokinetic drug—drug interactions exist between emtricitabine and other nucleoside antivirals that are extensively eliminated by renal excretion. Potential interactions with stavudine and famciclovir were evaluated in single‐dose studies, whereas interactions with zidovudine and its major metabolite, zidovudine glucuronide, were evaluated in a multiple‐dose study. Plasma pharmacokinetic profiles and, in some studies, urinary excretion data were evaluated when each drug was administered alone and in combination with emtricitabine. Safety and plasma pharmacokinetic profiles of each drug administered alone or with emtricitabine were consistent with historical data. Statistical analyses indicated that there were no significant interactions between emtricitabine and these 3 nucleoside antivirals. |
| doi_str_mv | 10.1177/0091270007300808 |
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Robert</creator><creatorcontrib>Zong, Jian ; Chittick, Gregory E. ; Wang, Laurene H. ; Hui, James ; Begley, John A. ; Blum, M. Robert</creatorcontrib><description>Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once‐daily drug in combination with other antiretroviral agents for the treatment of HIV infection. Several phase I studies were conducted in healthy volunteers over the course of clinical development to evaluate whether pharmacokinetic drug—drug interactions exist between emtricitabine and other nucleoside antivirals that are extensively eliminated by renal excretion. Potential interactions with stavudine and famciclovir were evaluated in single‐dose studies, whereas interactions with zidovudine and its major metabolite, zidovudine glucuronide, were evaluated in a multiple‐dose study. Plasma pharmacokinetic profiles and, in some studies, urinary excretion data were evaluated when each drug was administered alone and in combination with emtricitabine. Safety and plasma pharmacokinetic profiles of each drug administered alone or with emtricitabine were consistent with historical data. Statistical analyses indicated that there were no significant interactions between emtricitabine and these 3 nucleoside antivirals.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1177/0091270007300808</identifier><identifier>PMID: 17526857</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject><![CDATA[2-Aminopurine - administration & dosage ; 2-Aminopurine - analogs & derivatives ; 2-Aminopurine - blood ; 2-Aminopurine - pharmacokinetics ; 2-Aminopurine - therapeutic use ; Adolescent ; Adult ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - blood ; Anti-HIV Agents - pharmacokinetics ; Anti-HIV Agents - therapeutic use ; antivirals ; Area Under Curve ; Cross-Over Studies ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - blood ; Deoxycytidine - pharmacokinetics ; Deoxycytidine - therapeutic use ; Dosage and administration ; Drug Interactions ; Drug therapy ; Drug Therapy, Combination ; Emtricitabine ; famciclovir ; Female ; HIV infection ; Human immunodeficiency virus ; Humans ; Male ; Middle Aged ; nucleoside reverse transcriptase inhibitor ; nucleosides ; penciclovir ; Pharmacokinetics ; Properties ; Reverse Transcriptase Inhibitors - administration & dosage ; Reverse Transcriptase Inhibitors - blood ; Reverse Transcriptase Inhibitors - pharmacokinetics ; Reverse Transcriptase Inhibitors - therapeutic use ; stavudine ; Stavudine - administration & dosage ; Stavudine - blood ; Stavudine - pharmacokinetics ; Stavudine - therapeutic use ; zidovudine ; Zidovudine - administration & dosage ; Zidovudine - blood ; Zidovudine - pharmacokinetics ; Zidovudine - therapeutic use]]></subject><ispartof>Journal of clinical pharmacology, 2007-07, Vol.47 (7), p.877-889</ispartof><rights>2007 American College of Clinical Pharmacology</rights><rights>COPYRIGHT 2007 Sage Publications, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4214-47841e6ba82dc2db12502ab64b22d30b7119fd931c503f2b68f9d51cf002e4a13</citedby><cites>FETCH-LOGICAL-c4214-47841e6ba82dc2db12502ab64b22d30b7119fd931c503f2b68f9d51cf002e4a13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1177%2F0091270007300808$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1177%2F0091270007300808$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17526857$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zong, Jian</creatorcontrib><creatorcontrib>Chittick, Gregory E.</creatorcontrib><creatorcontrib>Wang, Laurene H.</creatorcontrib><creatorcontrib>Hui, James</creatorcontrib><creatorcontrib>Begley, John A.</creatorcontrib><creatorcontrib>Blum, M. Robert</creatorcontrib><title>Pharmacokinetic Evaluation of Emtricitabine in Combination With Other Nucleoside Antivirals in Healthy Volunteers</title><title>Journal of clinical pharmacology</title><addtitle>J Clin Pharmacol</addtitle><description>Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once‐daily drug in combination with other antiretroviral agents for the treatment of HIV infection. Several phase I studies were conducted in healthy volunteers over the course of clinical development to evaluate whether pharmacokinetic drug—drug interactions exist between emtricitabine and other nucleoside antivirals that are extensively eliminated by renal excretion. Potential interactions with stavudine and famciclovir were evaluated in single‐dose studies, whereas interactions with zidovudine and its major metabolite, zidovudine glucuronide, were evaluated in a multiple‐dose study. Plasma pharmacokinetic profiles and, in some studies, urinary excretion data were evaluated when each drug was administered alone and in combination with emtricitabine. Safety and plasma pharmacokinetic profiles of each drug administered alone or with emtricitabine were consistent with historical data. Statistical analyses indicated that there were no significant interactions between emtricitabine and these 3 nucleoside antivirals.</description><subject>2-Aminopurine - administration & dosage</subject><subject>2-Aminopurine - analogs & derivatives</subject><subject>2-Aminopurine - blood</subject><subject>2-Aminopurine - pharmacokinetics</subject><subject>2-Aminopurine - therapeutic use</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - blood</subject><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>antivirals</subject><subject>Area Under Curve</subject><subject>Cross-Over Studies</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - blood</subject><subject>Deoxycytidine - pharmacokinetics</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Dosage and administration</subject><subject>Drug Interactions</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Emtricitabine</subject><subject>famciclovir</subject><subject>Female</subject><subject>HIV infection</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>nucleoside reverse transcriptase inhibitor</subject><subject>nucleosides</subject><subject>penciclovir</subject><subject>Pharmacokinetics</subject><subject>Properties</subject><subject>Reverse Transcriptase Inhibitors - administration & dosage</subject><subject>Reverse Transcriptase Inhibitors - blood</subject><subject>Reverse Transcriptase Inhibitors - pharmacokinetics</subject><subject>Reverse Transcriptase Inhibitors - therapeutic use</subject><subject>stavudine</subject><subject>Stavudine - administration & dosage</subject><subject>Stavudine - blood</subject><subject>Stavudine - pharmacokinetics</subject><subject>Stavudine - therapeutic use</subject><subject>zidovudine</subject><subject>Zidovudine - administration & dosage</subject><subject>Zidovudine - blood</subject><subject>Zidovudine - pharmacokinetics</subject><subject>Zidovudine - therapeutic use</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1v1DAQxS0EokvhzgnlxC1lxrHj5Lhatl3Q0lZ8VeJiOY7DmiZxazuF_e_xKiuQuCAfbM17v5mRHyEvEc4QhXgDUCMVACAKgAqqR2SBnNOclcAek8VBzg_6CXkWwg8ALBnHp-QEBadlxcWC3F_vlB-Udrd2NNHqbP2g-klF68bMddl6iN5qG1WT5MyO2coN6TnrNzbusqu4Mz67nHRvXLCtyZZjtA_Wqz4c_Buj-rjbZ19dP43RGB-ekyddEs2L431KvpyvP682-fbq4t1quc01o8hyJiqGpmxURVtN2wYpB6qakjWUtgU0ArHu2rpAzaHoaFNWXd1y1B0ANUxhcUpez33vvLufTIhysEGbvlejcVOQFMpalIIm49ls_K56I-3YueiVTqc1g9VuNJ1N9SXWRYW0YiwBMAPauxC86eSdt4Pye4kgD7nIf3NJyKvjMlMzmPYvcAwiGcrZ8DMN2_-3oXy_ut7w9E8JzGfQhmh-_QGVv5WlKASXN5cXcsU-fXyL2w_yW_EbNWunAw</recordid><startdate>200707</startdate><enddate>200707</enddate><creator>Zong, Jian</creator><creator>Chittick, Gregory E.</creator><creator>Wang, Laurene H.</creator><creator>Hui, James</creator><creator>Begley, John A.</creator><creator>Blum, M. Robert</creator><general>Blackwell Publishing Ltd</general><general>Sage Publications, Inc</general><scope>BSCLL</scope><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>7T2</scope><scope>7U2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>200707</creationdate><title>Pharmacokinetic Evaluation of Emtricitabine in Combination With Other Nucleoside Antivirals in Healthy Volunteers</title><author>Zong, Jian ; Chittick, Gregory E. ; Wang, Laurene H. ; Hui, James ; Begley, John A. ; Blum, M. Robert</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4214-47841e6ba82dc2db12502ab64b22d30b7119fd931c503f2b68f9d51cf002e4a13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>2-Aminopurine - administration & dosage</topic><topic>2-Aminopurine - analogs & derivatives</topic><topic>2-Aminopurine - blood</topic><topic>2-Aminopurine - pharmacokinetics</topic><topic>2-Aminopurine - therapeutic use</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - blood</topic><topic>Anti-HIV Agents - pharmacokinetics</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>antivirals</topic><topic>Area Under Curve</topic><topic>Cross-Over Studies</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - blood</topic><topic>Deoxycytidine - pharmacokinetics</topic><topic>Deoxycytidine - therapeutic use</topic><topic>Dosage and administration</topic><topic>Drug Interactions</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Emtricitabine</topic><topic>famciclovir</topic><topic>Female</topic><topic>HIV infection</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>nucleoside reverse transcriptase inhibitor</topic><topic>nucleosides</topic><topic>penciclovir</topic><topic>Pharmacokinetics</topic><topic>Properties</topic><topic>Reverse Transcriptase Inhibitors - administration & dosage</topic><topic>Reverse Transcriptase Inhibitors - blood</topic><topic>Reverse Transcriptase Inhibitors - pharmacokinetics</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>stavudine</topic><topic>Stavudine - administration & dosage</topic><topic>Stavudine - blood</topic><topic>Stavudine - pharmacokinetics</topic><topic>Stavudine - therapeutic use</topic><topic>zidovudine</topic><topic>Zidovudine - administration & dosage</topic><topic>Zidovudine - blood</topic><topic>Zidovudine - pharmacokinetics</topic><topic>Zidovudine - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zong, Jian</creatorcontrib><creatorcontrib>Chittick, Gregory E.</creatorcontrib><creatorcontrib>Wang, Laurene H.</creatorcontrib><creatorcontrib>Hui, James</creatorcontrib><creatorcontrib>Begley, John A.</creatorcontrib><creatorcontrib>Blum, M. Robert</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Safety Science and Risk</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zong, Jian</au><au>Chittick, Gregory E.</au><au>Wang, Laurene H.</au><au>Hui, James</au><au>Begley, John A.</au><au>Blum, M. Robert</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetic Evaluation of Emtricitabine in Combination With Other Nucleoside Antivirals in Healthy Volunteers</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>2007-07</date><risdate>2007</risdate><volume>47</volume><issue>7</issue><spage>877</spage><epage>889</epage><pages>877-889</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><abstract>Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once‐daily drug in combination with other antiretroviral agents for the treatment of HIV infection. Several phase I studies were conducted in healthy volunteers over the course of clinical development to evaluate whether pharmacokinetic drug—drug interactions exist between emtricitabine and other nucleoside antivirals that are extensively eliminated by renal excretion. Potential interactions with stavudine and famciclovir were evaluated in single‐dose studies, whereas interactions with zidovudine and its major metabolite, zidovudine glucuronide, were evaluated in a multiple‐dose study. Plasma pharmacokinetic profiles and, in some studies, urinary excretion data were evaluated when each drug was administered alone and in combination with emtricitabine. Safety and plasma pharmacokinetic profiles of each drug administered alone or with emtricitabine were consistent with historical data. Statistical analyses indicated that there were no significant interactions between emtricitabine and these 3 nucleoside antivirals.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>17526857</pmid><doi>10.1177/0091270007300808</doi><tpages>13</tpages></addata></record> |
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| ispartof | Journal of clinical pharmacology, 2007-07, Vol.47 (7), p.877-889 |
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| subjects | 2-Aminopurine - administration & dosage 2-Aminopurine - analogs & derivatives 2-Aminopurine - blood 2-Aminopurine - pharmacokinetics 2-Aminopurine - therapeutic use Adolescent Adult Anti-HIV Agents - administration & dosage Anti-HIV Agents - blood Anti-HIV Agents - pharmacokinetics Anti-HIV Agents - therapeutic use antivirals Area Under Curve Cross-Over Studies Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Deoxycytidine - blood Deoxycytidine - pharmacokinetics Deoxycytidine - therapeutic use Dosage and administration Drug Interactions Drug therapy Drug Therapy, Combination Emtricitabine famciclovir Female HIV infection Human immunodeficiency virus Humans Male Middle Aged nucleoside reverse transcriptase inhibitor nucleosides penciclovir Pharmacokinetics Properties Reverse Transcriptase Inhibitors - administration & dosage Reverse Transcriptase Inhibitors - blood Reverse Transcriptase Inhibitors - pharmacokinetics Reverse Transcriptase Inhibitors - therapeutic use stavudine Stavudine - administration & dosage Stavudine - blood Stavudine - pharmacokinetics Stavudine - therapeutic use zidovudine Zidovudine - administration & dosage Zidovudine - blood Zidovudine - pharmacokinetics Zidovudine - therapeutic use |
| title | Pharmacokinetic Evaluation of Emtricitabine in Combination With Other Nucleoside Antivirals in Healthy Volunteers |
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