Study of the Safety of Intravenous Artesunate (NCT00292929) | Clinical Trial Compass
CompletedPhase 1
Study of the Safety of Intravenous Artesunate
United States40 participants
Plain-language summary
The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a single dose of the antimalarial drug artesunate.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 labor…
Trial details
NCT IDNCT00292929
SponsorU.S. Army Medical Research and Development Command