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

Volumn 58, Issue 10, 2014, Pages 6209-6214

  Leong, F Joel ^a   Li, Ruobing ^b   Jain, Jay Prakash ^c   Lefèvre, Gilbert ^d   Magnusson, Baldur ^d   Diagana, Thierry T ^a   Partel, Peter ^e  

^a Novartis Institute for Tropical Diseases   (Singapore)

^b China Novartis Institutes for BioMedical Research Co   (China)

^c Novartis Healthcare Private Limited   (India)

^d NOVARTIS PHARMA AG   (Switzerland)

^e NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

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;

EID: 84907916563     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.03393-14     Document Type: Article

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