Malaria Clinical Trial
Official title:
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
Verified date | March 2007 |
Source | U.S. Army Medical Research and Materiel Command |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a single dose of the antimalarial drug artesunate.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Uniformed Services University of the Health Sciences | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Materiel Command |
United States,
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