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 multiple dose of the antimalarial drug artesunate.
Drug: Intravenous artesunate
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
||A Phase 1 Double-Blind, Placebo-Controlled, Randomized Multiple Dose Escalation Study to Evaluate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of a New GMP Formulation of Intravenous Artesunate if Healthy Subjects
| Estimated Enrollment:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years to 55 Years (Adult)
|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 physical examination that demonstrates no clinically significant contraindication for participating in the study. This would include documentation of any abnormal movements suggesting neurological pathology and ECG tracings to document an abnormalities in cardiac conduction
- If female, have a negative serum pregnancy test at screening and urine pregnancy test on pre-admission and admission, or be postmenopausal, or have had a hysterectomy, or have been sterilized, AND, if still able to bear children, agree to practice effective contraception for the duration of the study and for a period of 12 weeks after stopping study drug.
- Active duty participants must be on leave during the inpatient phase of the study.
- 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 important physical findings, laboratory abnormalities, or histories of Rx or OTC drug use that may, in the judgement of a study investigator, impact study interpretation or affect subject safety
- Have used any prescription drugs within 14 days prior to admission or most non-prescription drugs including herbals or dietary supplements within 7 days prior to admission (at the investigator's discretion).
- 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 artemisinin derivatives
- CAGE (screening test for alcoholism) postitive (2 out of 4 criteria) or has a history of recent alcohol abuse
- Use of illicit drugs
- Family history (in 1st degree relatives) of sudden cardiac death or prolonged QT/QTc syndrome
- History of seizure (excluding febrile seizures in childhood), episodes of unexplained syncope, or trouble with balance, undiagnosed hearing deficits, and 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
- A finding or history of hematuria (excluding menses-related hematuria) during subject screening
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292942
|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)
History of Changes
|Other Study ID Numbers:
|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 October 25, 2016
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases