Study of the Safety of Intravenous Artesunate
This study has been completed.
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
First received: February 14, 2006
Last updated: April 10, 2007
Last verified: March 2007
The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a single dose of the antimalarial drug artesunate.
Drug: Intravenous artesunate
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
||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
| Estimated Enrollment:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292929
|Uniformed Services University of the Health Sciences
|Bethesda, Maryland, United States, 20814-4799 |
U.S. Army Office of the Surgeon General
||Peter J Weina, MD, PhD
||Walter Reed Army Institute of Research (WRAIR)
No publications provided
History of Changes
|Other Study ID Numbers:
||WRAIR 1128, USUHS G183RW, HSRRB A-13276
|Study First Received:
||February 14, 2006
||April 10, 2007
||United States: Food and Drug Administration
Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases