Status:
COMPLETED
Study of the Safety of Intravenous Artesunate
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Malaria
Malaria, Cerebral
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00292929
End Date
October 1 2006
Last Update
October 26 2016
Active Locations (1)
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1
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States, 20814-4799