First Human Study of the Investigational Sedative and Anesthetic Drug AZD3043: A Dose-Escalation Trial to Assess the Safety, Pharmacokinetics, and Efficacy of a 30-Minute Infusion in Healthy Male Volunteers
BACKGROUND:AZD3043 is a positive allosteric modulator of the γ-aminobutyric acid type A receptor that is rapidly metabolized to an inactive metabolite by esterases present in blood and liver. Preclinical results suggest that AZD3043 has the potential as a short-acting IV sedative/anesthetic drug wit...
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description | BACKGROUND:AZD3043 is a positive allosteric modulator of the γ-aminobutyric acid type A receptor that is rapidly metabolized to an inactive metabolite by esterases present in blood and liver. Preclinical results suggest that AZD3043 has the potential as a short-acting IV sedative/anesthetic drug with rapid and predictable recovery characteristics and a favorable safety and tolerability profile.
METHODS:Our primary objective in this phase 1, single-center, open-label study was to evaluate the safety and tolerability of AZD3043 after IV infusion and to estimate the maximal tolerated dose. Secondary objectives included the evaluation of AZD3043 pharmacokinetics, pharmacodynamics, and efficacy. Sequential ascending-dose cohorts of 5 or 6 healthy male volunteers aged 18 to 45 years received a single 30-minute IV infusion of AZD3043. Assessments included adverse events, vital signs, blood gases, laboratory values, clinical signs of sedation/anesthesia, and bispectral index.
RESULTS:Fifty-three subjects received AZD3043 in infusion rate cohorts of 1, 3, 6, 12, 18, 27, 36, 54, and 81 mg/kg/h. There were no discontinuations, and dose escalation was stopped on reaching the predefined exposure limit. Adverse events occurring in >1 subject were headache (n = 4), erythema (n = 3), chest discomfort (n = 2), nausea (n = 2), and dyspnea (n = 2). The frequency and character of adverse events appeared unrelated to dose. There were no spontaneous reports of pain on injection and no clinically relevant changes in respiratory rate or arterial blood pressure. However, heart rate increased dose-dependently at infusion rates >18 mg/kg/h. Occurrence of sedation/anesthesia corresponded with dose; the lowest applied infusion rate to induce anesthesia according to clinical signs of sedation/anesthesia at predefined time points was 12 mg/kg/h (1 of 6 subjects anesthetized), and all subjects in the 3 highest dose groups were anesthetized. The onset of anesthesia ranged from 4 minutes in the highest infusion rate group to 29 minutes in the 12-mg/kg/h infusion rate group. Return of response to oral command occurred at 3 minutes after the end of infusion in the single subject who was anesthetized in the 12-mg/kg/h group and median 25 minutes in the 81-mg/kg/h group. Involuntary movements ranging from minor twitches to extensive movements were accompanied by increased muscle tone.
CONCLUSIONS:AZD3043 was well tolerated in this first human study and seems to exhibit rapid onset and recovery |
doi_str_mv | 10.1213/ANE.0000000000000831 |
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METHODS:Our primary objective in this phase 1, single-center, open-label study was to evaluate the safety and tolerability of AZD3043 after IV infusion and to estimate the maximal tolerated dose. Secondary objectives included the evaluation of AZD3043 pharmacokinetics, pharmacodynamics, and efficacy. Sequential ascending-dose cohorts of 5 or 6 healthy male volunteers aged 18 to 45 years received a single 30-minute IV infusion of AZD3043. Assessments included adverse events, vital signs, blood gases, laboratory values, clinical signs of sedation/anesthesia, and bispectral index.
RESULTS:Fifty-three subjects received AZD3043 in infusion rate cohorts of 1, 3, 6, 12, 18, 27, 36, 54, and 81 mg/kg/h. There were no discontinuations, and dose escalation was stopped on reaching the predefined exposure limit. Adverse events occurring in >1 subject were headache (n = 4), erythema (n = 3), chest discomfort (n = 2), nausea (n = 2), and dyspnea (n = 2). The frequency and character of adverse events appeared unrelated to dose. There were no spontaneous reports of pain on injection and no clinically relevant changes in respiratory rate or arterial blood pressure. However, heart rate increased dose-dependently at infusion rates >18 mg/kg/h. Occurrence of sedation/anesthesia corresponded with dose; the lowest applied infusion rate to induce anesthesia according to clinical signs of sedation/anesthesia at predefined time points was 12 mg/kg/h (1 of 6 subjects anesthetized), and all subjects in the 3 highest dose groups were anesthetized. The onset of anesthesia ranged from 4 minutes in the highest infusion rate group to 29 minutes in the 12-mg/kg/h infusion rate group. Return of response to oral command occurred at 3 minutes after the end of infusion in the single subject who was anesthetized in the 12-mg/kg/h group and median 25 minutes in the 81-mg/kg/h group. Involuntary movements ranging from minor twitches to extensive movements were accompanied by increased muscle tone.
CONCLUSIONS:AZD3043 was well tolerated in this first human study and seems to exhibit rapid onset and recovery, indicating potential use as a short-acting drug for anesthesia and sedation.</description><identifier>ISSN: 0003-2999</identifier><identifier>EISSN: 1526-7598</identifier><identifier>DOI: 10.1213/ANE.0000000000000831</identifier><identifier>PMID: 26111262</identifier><language>eng</language><publisher>United States: International Anesthesia Research Society</publisher><subject>Adolescent ; Adult ; Dose-Response Relationship, Drug ; Drugs, Investigational - administration & dosage ; Drugs, Investigational - adverse effects ; Drugs, Investigational - pharmacokinetics ; Erythema - chemically induced ; Headache - chemically induced ; Healthy Volunteers ; Humans ; Hypnotics and Sedatives - administration & dosage ; Hypnotics and Sedatives - adverse effects ; Hypnotics and Sedatives - pharmacokinetics ; Infusions, Intravenous ; Male ; Phenylacetates - administration & dosage ; Phenylacetates - adverse effects ; Phenylacetates - pharmacokinetics ; Receptors, GABA-A - drug effects ; Time Factors ; Treatment Outcome ; Young Adult</subject><ispartof>Anesthesia and analgesia, 2015-10, Vol.121 (4), p.885-893</ispartof><rights>International Anesthesia Research Society</rights><rights>2015 International Anesthesia Research Society</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3881-7ed717240d2b5e67fded77fcfd7ef61bc9531e131292c6f5fe8e287a522e0c7b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttp://ovidsp.ovid.com/ovidweb.cgi?T=JS&NEWS=n&CSC=Y&PAGE=fulltext&D=ovft&AN=00000539-201510000-00011$$EHTML$$P50$$Gwolterskluwer$$H</linktohtml><link.rule.ids>230,314,776,780,881,4595,27901,27902,65206</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26111262$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:132933157$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Kalman, Sigridur</creatorcontrib><creatorcontrib>Koch, Pauline</creatorcontrib><creatorcontrib>Ahlén, Kjell</creatorcontrib><creatorcontrib>Kanes, Stephen J.</creatorcontrib><creatorcontrib>Barassin, Stéphane</creatorcontrib><creatorcontrib>Björnsson, Marcus A.</creatorcontrib><creatorcontrib>Norberg, Åke</creatorcontrib><title>First Human Study of the Investigational Sedative and Anesthetic Drug AZD3043: A Dose-Escalation Trial to Assess the Safety, Pharmacokinetics, and Efficacy of a 30-Minute Infusion in Healthy Male Volunteers</title><title>Anesthesia and analgesia</title><addtitle>Anesth Analg</addtitle><description>BACKGROUND:AZD3043 is a positive allosteric modulator of the γ-aminobutyric acid type A receptor that is rapidly metabolized to an inactive metabolite by esterases present in blood and liver. Preclinical results suggest that AZD3043 has the potential as a short-acting IV sedative/anesthetic drug with rapid and predictable recovery characteristics and a favorable safety and tolerability profile.
METHODS:Our primary objective in this phase 1, single-center, open-label study was to evaluate the safety and tolerability of AZD3043 after IV infusion and to estimate the maximal tolerated dose. Secondary objectives included the evaluation of AZD3043 pharmacokinetics, pharmacodynamics, and efficacy. Sequential ascending-dose cohorts of 5 or 6 healthy male volunteers aged 18 to 45 years received a single 30-minute IV infusion of AZD3043. Assessments included adverse events, vital signs, blood gases, laboratory values, clinical signs of sedation/anesthesia, and bispectral index.
RESULTS:Fifty-three subjects received AZD3043 in infusion rate cohorts of 1, 3, 6, 12, 18, 27, 36, 54, and 81 mg/kg/h. There were no discontinuations, and dose escalation was stopped on reaching the predefined exposure limit. Adverse events occurring in >1 subject were headache (n = 4), erythema (n = 3), chest discomfort (n = 2), nausea (n = 2), and dyspnea (n = 2). The frequency and character of adverse events appeared unrelated to dose. There were no spontaneous reports of pain on injection and no clinically relevant changes in respiratory rate or arterial blood pressure. However, heart rate increased dose-dependently at infusion rates >18 mg/kg/h. Occurrence of sedation/anesthesia corresponded with dose; the lowest applied infusion rate to induce anesthesia according to clinical signs of sedation/anesthesia at predefined time points was 12 mg/kg/h (1 of 6 subjects anesthetized), and all subjects in the 3 highest dose groups were anesthetized. The onset of anesthesia ranged from 4 minutes in the highest infusion rate group to 29 minutes in the 12-mg/kg/h infusion rate group. Return of response to oral command occurred at 3 minutes after the end of infusion in the single subject who was anesthetized in the 12-mg/kg/h group and median 25 minutes in the 81-mg/kg/h group. Involuntary movements ranging from minor twitches to extensive movements were accompanied by increased muscle tone.
CONCLUSIONS:AZD3043 was well tolerated in this first human study and seems to exhibit rapid onset and recovery, indicating potential use as a short-acting drug for anesthesia and sedation.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drugs, Investigational - administration & dosage</subject><subject>Drugs, Investigational - adverse effects</subject><subject>Drugs, Investigational - pharmacokinetics</subject><subject>Erythema - chemically induced</subject><subject>Headache - chemically induced</subject><subject>Healthy Volunteers</subject><subject>Humans</subject><subject>Hypnotics and Sedatives - administration & dosage</subject><subject>Hypnotics and Sedatives - adverse effects</subject><subject>Hypnotics and Sedatives - pharmacokinetics</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Phenylacetates - administration & dosage</subject><subject>Phenylacetates - adverse effects</subject><subject>Phenylacetates - pharmacokinetics</subject><subject>Receptors, GABA-A - drug effects</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0003-2999</issn><issn>1526-7598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUl1v0zAUjRCIlcE_QMg_YB6-dp0P3qK1o5M2QOrggZfIda4X0zSZbGdV_yS_CScdE-IB_OJ7j885uvZxkrwFdg4cxPvy0_Kc_blyAc-SGUie0kwW-fNkFkFBeVEUJ8kr73_EFlievkxOeAoAPOWz5OeldT6Q1bBTHVmHoT6Q3pDQILnqHtAHe6eC7TvVkjXWsXxAorqalF08azBYTRZuuCPl94Vgc_GBlGTRe6RLr1U7Kcmts1EdelJ6j95P3mtlMBzOyJdGuZ3S_dZ2o5c_m8yXxlit9DSJIoLRG9sNYZzIDH60tB1ZoWpDcyA3qkXyrW-HLiA6_zp5YVTr8c3jfpp8vVzeXqzo9eePVxflNdUiz4FmWGeQ8Tmr-UZimpk6ApnRps7QpLDRhRSAIIAXXKdGGsyR55mSnCPT2UacJvTo6_d4P2yqe2d3yh2qXtnqEdrGCisJXLIi8udHvna99w7NkwJYNcZZxTirv-OMsndHWTTcYf0k-p1fJORHwr5vQ7z_th326Kpmep3_ec__IZ1oUhSUM5AwNnT8PiB-AW2Fvbo</recordid><startdate>201510</startdate><enddate>201510</enddate><creator>Kalman, Sigridur</creator><creator>Koch, Pauline</creator><creator>Ahlén, Kjell</creator><creator>Kanes, Stephen J.</creator><creator>Barassin, Stéphane</creator><creator>Björnsson, Marcus A.</creator><creator>Norberg, Åke</creator><general>International Anesthesia Research Society</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>ADTPV</scope><scope>AOWAS</scope></search><sort><creationdate>201510</creationdate><title>First Human Study of the Investigational Sedative and Anesthetic Drug AZD3043: A Dose-Escalation Trial to Assess the Safety, Pharmacokinetics, and Efficacy of a 30-Minute Infusion in Healthy Male Volunteers</title><author>Kalman, Sigridur ; Koch, Pauline ; Ahlén, Kjell ; Kanes, Stephen J. ; Barassin, Stéphane ; Björnsson, Marcus A. ; Norberg, Åke</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3881-7ed717240d2b5e67fded77fcfd7ef61bc9531e131292c6f5fe8e287a522e0c7b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drugs, Investigational - administration & dosage</topic><topic>Drugs, Investigational - adverse effects</topic><topic>Drugs, Investigational - pharmacokinetics</topic><topic>Erythema - chemically induced</topic><topic>Headache - chemically induced</topic><topic>Healthy Volunteers</topic><topic>Humans</topic><topic>Hypnotics and Sedatives - administration & dosage</topic><topic>Hypnotics and Sedatives - adverse effects</topic><topic>Hypnotics and Sedatives - pharmacokinetics</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Phenylacetates - administration & dosage</topic><topic>Phenylacetates - adverse effects</topic><topic>Phenylacetates - pharmacokinetics</topic><topic>Receptors, GABA-A - drug effects</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kalman, Sigridur</creatorcontrib><creatorcontrib>Koch, Pauline</creatorcontrib><creatorcontrib>Ahlén, Kjell</creatorcontrib><creatorcontrib>Kanes, Stephen J.</creatorcontrib><creatorcontrib>Barassin, Stéphane</creatorcontrib><creatorcontrib>Björnsson, Marcus A.</creatorcontrib><creatorcontrib>Norberg, Åke</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>SwePub</collection><collection>SwePub Articles</collection><jtitle>Anesthesia and analgesia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kalman, Sigridur</au><au>Koch, Pauline</au><au>Ahlén, Kjell</au><au>Kanes, Stephen J.</au><au>Barassin, Stéphane</au><au>Björnsson, Marcus A.</au><au>Norberg, Åke</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>First Human Study of the Investigational Sedative and Anesthetic Drug AZD3043: A Dose-Escalation Trial to Assess the Safety, Pharmacokinetics, and Efficacy of a 30-Minute Infusion in Healthy Male Volunteers</atitle><jtitle>Anesthesia and analgesia</jtitle><addtitle>Anesth Analg</addtitle><date>2015-10</date><risdate>2015</risdate><volume>121</volume><issue>4</issue><spage>885</spage><epage>893</epage><pages>885-893</pages><issn>0003-2999</issn><eissn>1526-7598</eissn><abstract>BACKGROUND:AZD3043 is a positive allosteric modulator of the γ-aminobutyric acid type A receptor that is rapidly metabolized to an inactive metabolite by esterases present in blood and liver. Preclinical results suggest that AZD3043 has the potential as a short-acting IV sedative/anesthetic drug with rapid and predictable recovery characteristics and a favorable safety and tolerability profile.
METHODS:Our primary objective in this phase 1, single-center, open-label study was to evaluate the safety and tolerability of AZD3043 after IV infusion and to estimate the maximal tolerated dose. Secondary objectives included the evaluation of AZD3043 pharmacokinetics, pharmacodynamics, and efficacy. Sequential ascending-dose cohorts of 5 or 6 healthy male volunteers aged 18 to 45 years received a single 30-minute IV infusion of AZD3043. Assessments included adverse events, vital signs, blood gases, laboratory values, clinical signs of sedation/anesthesia, and bispectral index.
RESULTS:Fifty-three subjects received AZD3043 in infusion rate cohorts of 1, 3, 6, 12, 18, 27, 36, 54, and 81 mg/kg/h. There were no discontinuations, and dose escalation was stopped on reaching the predefined exposure limit. Adverse events occurring in >1 subject were headache (n = 4), erythema (n = 3), chest discomfort (n = 2), nausea (n = 2), and dyspnea (n = 2). The frequency and character of adverse events appeared unrelated to dose. There were no spontaneous reports of pain on injection and no clinically relevant changes in respiratory rate or arterial blood pressure. However, heart rate increased dose-dependently at infusion rates >18 mg/kg/h. Occurrence of sedation/anesthesia corresponded with dose; the lowest applied infusion rate to induce anesthesia according to clinical signs of sedation/anesthesia at predefined time points was 12 mg/kg/h (1 of 6 subjects anesthetized), and all subjects in the 3 highest dose groups were anesthetized. The onset of anesthesia ranged from 4 minutes in the highest infusion rate group to 29 minutes in the 12-mg/kg/h infusion rate group. Return of response to oral command occurred at 3 minutes after the end of infusion in the single subject who was anesthetized in the 12-mg/kg/h group and median 25 minutes in the 81-mg/kg/h group. Involuntary movements ranging from minor twitches to extensive movements were accompanied by increased muscle tone.
CONCLUSIONS:AZD3043 was well tolerated in this first human study and seems to exhibit rapid onset and recovery, indicating potential use as a short-acting drug for anesthesia and sedation.</abstract><cop>United States</cop><pub>International Anesthesia Research Society</pub><pmid>26111262</pmid><doi>10.1213/ANE.0000000000000831</doi><tpages>9</tpages></addata></record> |
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subjects | Adolescent Adult Dose-Response Relationship, Drug Drugs, Investigational - administration & dosage Drugs, Investigational - adverse effects Drugs, Investigational - pharmacokinetics Erythema - chemically induced Headache - chemically induced Healthy Volunteers Humans Hypnotics and Sedatives - administration & dosage Hypnotics and Sedatives - adverse effects Hypnotics and Sedatives - pharmacokinetics Infusions, Intravenous Male Phenylacetates - administration & dosage Phenylacetates - adverse effects Phenylacetates - pharmacokinetics Receptors, GABA-A - drug effects Time Factors Treatment Outcome Young Adult |
title | First Human Study of the Investigational Sedative and Anesthetic Drug AZD3043: A Dose-Escalation Trial to Assess the Safety, Pharmacokinetics, and Efficacy of a 30-Minute Infusion in Healthy Male Volunteers |
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