A Phase 1 Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of Artesunate Administered to Healthy Subjects

U.S. Army Medical Research and Development Command1 site in 1 country40 target enrollmentFebruary 16, 2006

Overview

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

Registry

clinicaltrials.gov

Start Date

February 16, 2006

End Date

October 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

U.S. Army Medical Research and Development Command

•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.

•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