A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers

10.1128/AAC.03393-14

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Main Authors:	Leong, F.J, Li, R, Jain, J.P, Lefèvre, G, Magnusson, B, Diagana, T.T, Partel, P
Other Authors:	MICROBIOLOGY AND IMMUNOLOGY
Format:	Article
Published:	American Society for Microbiology 2020
Subjects:	alanine aminotransferase amylase aspartate aminotransferase bilirubin cipargamin creatine kinase fat lactate dehydrogenase liver enzyme paracetamol placebo triacylglycerol lipase antimalarial agent indole derivative spiro compound abdominal discomfort adult alanine aminotransferase blood level amylase blood level area under the curve Article aspartate aminotransferase blood level bilirubin blood level cohort analysis controlled study diarrhea dizziness double blind procedure drug absorption drug blood level drug clearance drug distribution drug efficacy drug elimination drug exposure drug half life drug induced headache drug safety drug tolerability enzyme blood level female follow up food intake gastrointestinal symptom hematoma human human experiment lactate dehydrogenase blood level lipid diet male maximum plasma concentration nausea pharmacological parameters randomized controlled trial semen abnormality side effect single drug dose time to maximum plasma concentration triacylglycerol lipase blood level urinalysis dose response drug administration normal human Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Healthy Volunteers Humans Indoles Spiro Compounds
Online Access:	https://scholarbank.nus.edu.sg/handle/10635/180137
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Institution:	National University of Singapore

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spelling	sg-nus-scholar.10635-1801372024-03-27T08:19:29Z A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers Leong, F.J Li, R Jain, J.P Lefèvre, G Magnusson, B Diagana, T.T Partel, P MICROBIOLOGY AND IMMUNOLOGY alanine aminotransferase amylase aspartate aminotransferase bilirubin cipargamin creatine kinase fat lactate dehydrogenase liver enzyme paracetamol placebo triacylglycerol lipase antimalarial agent cipargamin indole derivative spiro compound abdominal discomfort adult alanine aminotransferase blood level amylase blood level area under the curve Article aspartate aminotransferase blood level bilirubin blood level cohort analysis controlled study diarrhea dizziness double blind procedure drug absorption drug blood level drug clearance drug distribution drug efficacy drug elimination drug exposure drug half life drug induced headache drug safety drug tolerability enzyme blood level female follow up food intake gastrointestinal symptom hematoma human human experiment lactate dehydrogenase blood level lipid diet male maximum plasma concentration nausea pharmacological parameters randomized controlled trial semen abnormality side effect single drug dose time to maximum plasma concentration triacylglycerol lipase blood level urinalysis dose response drug administration normal human Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Healthy Volunteers Humans Indoles Spiro Compounds 10.1128/AAC.03393-14 Antimicrobial Agents and Chemotherapy 58 10 6209-6214 2020-10-26T07:10:28Z 2020-10-26T07:10:28Z 2014 Article Leong, F.J, Li, R, Jain, J.P, Lefèvre, G, Magnusson, B, Diagana, T.T, Partel, P (2014). A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers. Antimicrobial Agents and Chemotherapy 58 (10) : 6209-6214. ScholarBank@NUS Repository. https://doi.org/10.1128/AAC.03393-14 0066-4804 https://scholarbank.nus.edu.sg/handle/10635/180137 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ American Society for Microbiology Unpaywall 20201031
institution	National University of Singapore
building	NUS Library
continent	Asia
country	Singapore Singapore
content_provider	NUS Library
collection	ScholarBank@NUS
topic	alanine aminotransferase amylase aspartate aminotransferase bilirubin cipargamin creatine kinase fat lactate dehydrogenase liver enzyme paracetamol placebo triacylglycerol lipase antimalarial agent cipargamin indole derivative spiro compound abdominal discomfort adult alanine aminotransferase blood level amylase blood level area under the curve Article aspartate aminotransferase blood level bilirubin blood level cohort analysis controlled study diarrhea dizziness double blind procedure drug absorption drug blood level drug clearance drug distribution drug efficacy drug elimination drug exposure drug half life drug induced headache drug safety drug tolerability enzyme blood level female follow up food intake gastrointestinal symptom hematoma human human experiment lactate dehydrogenase blood level lipid diet male maximum plasma concentration nausea pharmacological parameters randomized controlled trial semen abnormality side effect single drug dose time to maximum plasma concentration triacylglycerol lipase blood level urinalysis dose response drug administration normal human Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Healthy Volunteers Humans Indoles Spiro Compounds
spellingShingle	alanine aminotransferase amylase aspartate aminotransferase bilirubin cipargamin creatine kinase fat lactate dehydrogenase liver enzyme paracetamol placebo triacylglycerol lipase antimalarial agent cipargamin indole derivative spiro compound abdominal discomfort adult alanine aminotransferase blood level amylase blood level area under the curve Article aspartate aminotransferase blood level bilirubin blood level cohort analysis controlled study diarrhea dizziness double blind procedure drug absorption drug blood level drug clearance drug distribution drug efficacy drug elimination drug exposure drug half life drug induced headache drug safety drug tolerability enzyme blood level female follow up food intake gastrointestinal symptom hematoma human human experiment lactate dehydrogenase blood level lipid diet male maximum plasma concentration nausea pharmacological parameters randomized controlled trial semen abnormality side effect single drug dose time to maximum plasma concentration triacylglycerol lipase blood level urinalysis dose response drug administration normal human Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Healthy Volunteers Humans Indoles Spiro Compounds Leong, F.J Li, R Jain, J.P Lefèvre, G Magnusson, B Diagana, T.T Partel, P A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
description	10.1128/AAC.03393-14
author2	MICROBIOLOGY AND IMMUNOLOGY
author_facet	MICROBIOLOGY AND IMMUNOLOGY Leong, F.J Li, R Jain, J.P Lefèvre, G Magnusson, B Diagana, T.T Partel, P
format	Article
author	Leong, F.J Li, R Jain, J.P Lefèvre, G Magnusson, B Diagana, T.T Partel, P
author_sort	Leong, F.J
title	A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
title_short	A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
title_full	A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
title_fullStr	A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
title_full_unstemmed	A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
title_sort	first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel antimalarial spiroindolone kae609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
publisher	American Society for Microbiology
publishDate	2020
url	https://scholarbank.nus.edu.sg/handle/10635/180137
_version_	1795301277141303296

A first-in-human randomized, double-blind, placebo-controlled, single- And multiple-ascending oral dose study of novel antimalarial spiroindolone KAE609 (cipargamin) to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers

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