Study of the Safety of Intravenous Artesunate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292942
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : October 27, 2016
Information provided by:
U.S. Army Medical Research and Materiel Command

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

Condition or disease Intervention/treatment Phase
Malaria Malaria, Cerebral Drug: Intravenous artesunate Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Completion Date : October 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 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.

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292942

United States, Maryland
Uniformed Services University of the HEalth Sciences
Bethesda, Maryland, United States, 20814-4799
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Study Director: Peter J Weina, MD, PhD Walter Reed Army Institute of Research (WRAIR) Identifier: NCT00292942     History of Changes
Other Study ID Numbers: WRAIR 1142
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: March 2007

Keywords provided by U.S. Army Medical Research and Materiel Command:

Additional relevant MeSH terms:
Malaria, Cerebral
Protozoan Infections
Parasitic Diseases
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents