study of the safety of intravenous artesunate

Conditions: Malaria; Malaria, Cerebral

Summary: the purpose of this study is to establish the safety, tolerability and pharmacokinetics of a single dose of the antimalarial drug artesunate.


Eligibility criteria:
inclusion criteria: * healthy adult males and non-pregnant, non-lactating females * have a normal ecg that may include benign pac's and pvc's, 1st degree av block, 2nd degree av block, wenckebach * have a normal blood pressure (bp) and heart rate (hr). these will be measured after resting supine for about 3 minutes. normal bp is defined as less than 140 mm hg systolic and less than 90 mm hg diastolic. normal baseline hr is 50 to 90 bpm without symptoms. * body mass index between 18 and 29 kg/m\*\*2 or, if out of range, not clinically significant (within 15% of their ideal body weight). * be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures * have a brief physical examination that demonstrates no clinically significant contraindication for participating in the study. * if female, have a negative serum pregnancy test at screening and urine pregnancy at admission or be postmenopausal, had a hysterectomy, been sterilized, or agrees to practice effective contraception for the duration fo the study and for a period of 12 weeks after stopping study drug. exclusion criteria: * have received any investigational drug or vaccine in the period 0 to 16 weeks before entry to the study. * have been on a liquid protein diet in the last year * have any clinically significant abnormal physical findings at the screening examination * have any clinically significant abnormalities in the results of laboratory screening evaluation * have used any prescription drugs within 14 days prior to admission or non-prescription drugs (including herbals or dietary supplements) within 7 days prior to admission * existence of any surgical or medical condition that, in the judgement of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug * presence of history of drug allergy requiring treatment. hay fever is allowed unless it is active or has required treatment within the previous 2 months * donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study. * serious adverse reaction or hypersensitivity to any drug, particularly artemisinins * cage (screening test for alcoholism) positive (2 out of 4 criteria) or has a history of recent alcohol abuse * use of illicit drugs * family history of sudden cardiac death or prolonged qt syndrome (defined as 500 msec noted in repeat tracings) * history of seizure, syncope, or trouble with hearing or balance or other neurological disorder * history of severe psychiatric disorder or hospitalization for severe psychiatric disorder * current job or personal habit of reversed sleep-wake cycle * history of cardiac disease to include cardiomyopathy, valvular disease, arrhythmia, ischemia, or enlarged heart * presence of hepatitis b surface antigen (hbs-ag), hepatitis c antibody (antihcv) or hiv type 1 at screening * pregnancy

Keywords: artesunate artemisinin falciparum