A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel imidazolopiperazine KAF156 to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers

10.1128/AAC.03478-14

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Main Authors:	Leong, F.J, Zhao, R, Zeng, S, Magnusson, B, Diagana, T.T, Pertel, P
Other Authors:	MICROBIOLOGY AND IMMUNOLOGY
Format:	Article
Published:	American Society for Microbiology 2020
Subjects:	alanine aminotransferase alkaline phosphatase antimalarial agent imidazolopiperazine placebo unclassified drug imidazole derivative KAF156 piperazine derivative abdominal pain adult alanine aminotransferase blood level alkaline phosphatase blood level application site excoriation area under the curve Article blood chemistry controlled study contusion diarrhea diet restriction dizziness dose calculation double blind procedure drug absorption drug blood level drug clearance drug half life drug induced headache drug safety drug tolerability drug withdrawal elimination half-life eye injury female first in human study follow up food intake gastritis gastrointestinal disease hematology hematuria human joint injury kidney clearance laceration limb pain major clinical study malaria male maximum plasma concentration nausea neuralgia neurologic disease oropharynx pain peripheral edema presyncope randomized controlled trial repeated drug dose rhinitis risk assessment side effect single drug dose systemic circulation time to maximum plasma concentration upper respiratory tract infection urinalysis urinary excretion volume of distribution vomiting adolescent dose response drug administration drug effects drug resistance intestine absorption middle aged normal human oral drug administration parasitology physiology Plasmodium falciparum Plasmodium vivax young adult Administration, Oral Adolescent Adult Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Resistance Female Healthy Volunteers Humans Imidazoles Intestinal Absorption Malaria Male Middle Aged Piperazines Placebos Young Adult
Online Access:	https://scholarbank.nus.edu.sg/handle/10635/180135
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Institution:	National University of Singapore

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spelling	sg-nus-scholar.10635-1801352024-03-27T08:19:18Z A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel imidazolopiperazine KAF156 to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers Leong, F.J Zhao, R Zeng, S Magnusson, B Diagana, T.T Pertel, P MICROBIOLOGY AND IMMUNOLOGY alanine aminotransferase alkaline phosphatase antimalarial agent imidazolopiperazine placebo unclassified drug antimalarial agent imidazole derivative KAF156 piperazine derivative abdominal pain adult alanine aminotransferase blood level alkaline phosphatase blood level application site excoriation area under the curve Article blood chemistry controlled study contusion diarrhea diet restriction dizziness dose calculation double blind procedure drug absorption drug blood level drug clearance drug half life drug induced headache drug safety drug tolerability drug withdrawal elimination half-life eye injury female first in human study follow up food intake gastritis gastrointestinal disease hematology hematuria human joint injury kidney clearance laceration limb pain major clinical study malaria male maximum plasma concentration nausea neuralgia neurologic disease oropharynx pain peripheral edema presyncope randomized controlled trial repeated drug dose rhinitis risk assessment side effect single drug dose systemic circulation time to maximum plasma concentration upper respiratory tract infection urinalysis urinary excretion volume of distribution vomiting adolescent dose response drug administration drug effects drug resistance intestine absorption malaria middle aged normal human oral drug administration parasitology physiology Plasmodium falciparum Plasmodium vivax young adult Administration, Oral Adolescent Adult Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Resistance Female Healthy Volunteers Humans Imidazoles Intestinal Absorption Malaria Male Middle Aged Piperazines Placebos Plasmodium falciparum Plasmodium vivax Young Adult 10.1128/AAC.03478-14 Antimicrobial Agents and Chemotherapy 58 11 6437-6443 2020-10-26T07:09:46Z 2020-10-26T07:09:46Z 2014 Article Leong, F.J, Zhao, R, Zeng, S, Magnusson, B, Diagana, T.T, Pertel, P (2014). A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel imidazolopiperazine KAF156 to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers. Antimicrobial Agents and Chemotherapy 58 (11) : 6437-6443. ScholarBank@NUS Repository. https://doi.org/10.1128/AAC.03478-14 0066-4804 https://scholarbank.nus.edu.sg/handle/10635/180135 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 alkaline phosphatase antimalarial agent imidazolopiperazine placebo unclassified drug antimalarial agent imidazole derivative KAF156 piperazine derivative abdominal pain adult alanine aminotransferase blood level alkaline phosphatase blood level application site excoriation area under the curve Article blood chemistry controlled study contusion diarrhea diet restriction dizziness dose calculation double blind procedure drug absorption drug blood level drug clearance drug half life drug induced headache drug safety drug tolerability drug withdrawal elimination half-life eye injury female first in human study follow up food intake gastritis gastrointestinal disease hematology hematuria human joint injury kidney clearance laceration limb pain major clinical study malaria male maximum plasma concentration nausea neuralgia neurologic disease oropharynx pain peripheral edema presyncope randomized controlled trial repeated drug dose rhinitis risk assessment side effect single drug dose systemic circulation time to maximum plasma concentration upper respiratory tract infection urinalysis urinary excretion volume of distribution vomiting adolescent dose response drug administration drug effects drug resistance intestine absorption malaria middle aged normal human oral drug administration parasitology physiology Plasmodium falciparum Plasmodium vivax young adult Administration, Oral Adolescent Adult Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Resistance Female Healthy Volunteers Humans Imidazoles Intestinal Absorption Malaria Male Middle Aged Piperazines Placebos Plasmodium falciparum Plasmodium vivax Young Adult
spellingShingle	alanine aminotransferase alkaline phosphatase antimalarial agent imidazolopiperazine placebo unclassified drug antimalarial agent imidazole derivative KAF156 piperazine derivative abdominal pain adult alanine aminotransferase blood level alkaline phosphatase blood level application site excoriation area under the curve Article blood chemistry controlled study contusion diarrhea diet restriction dizziness dose calculation double blind procedure drug absorption drug blood level drug clearance drug half life drug induced headache drug safety drug tolerability drug withdrawal elimination half-life eye injury female first in human study follow up food intake gastritis gastrointestinal disease hematology hematuria human joint injury kidney clearance laceration limb pain major clinical study malaria male maximum plasma concentration nausea neuralgia neurologic disease oropharynx pain peripheral edema presyncope randomized controlled trial repeated drug dose rhinitis risk assessment side effect single drug dose systemic circulation time to maximum plasma concentration upper respiratory tract infection urinalysis urinary excretion volume of distribution vomiting adolescent dose response drug administration drug effects drug resistance intestine absorption malaria middle aged normal human oral drug administration parasitology physiology Plasmodium falciparum Plasmodium vivax young adult Administration, Oral Adolescent Adult Antimalarials Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Resistance Female Healthy Volunteers Humans Imidazoles Intestinal Absorption Malaria Male Middle Aged Piperazines Placebos Plasmodium falciparum Plasmodium vivax Young Adult Leong, F.J Zhao, R Zeng, S Magnusson, B Diagana, T.T Pertel, P A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel imidazolopiperazine KAF156 to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers
description	10.1128/AAC.03478-14
author2	MICROBIOLOGY AND IMMUNOLOGY
author_facet	MICROBIOLOGY AND IMMUNOLOGY Leong, F.J Zhao, R Zeng, S Magnusson, B Diagana, T.T Pertel, P
format	Article
author	Leong, F.J Zhao, R Zeng, S Magnusson, B Diagana, T.T Pertel, 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 imidazolopiperazine KAF156 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 imidazolopiperazine KAF156 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 imidazolopiperazine KAF156 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 imidazolopiperazine KAF156 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 imidazolopiperazine KAF156 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 imidazolopiperazine kaf156 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/10635/180135
_version_	1795301276438757376

A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel imidazolopiperazine KAF156 to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers

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