Study of the Safety of Intravenous Artesunate

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Artemisinins; Artesunate

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