Study of the Safety of Intravenous Artesunate

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00292929
First received: February 14, 2006
Last updated: April 10, 2007
Last verified: March 2007
  Purpose

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


Condition Intervention Phase
Malaria
Malaria, Cerebral
Drug: Intravenous artesunate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Estimated Enrollment: 40
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292929

Locations
United States, Maryland
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States, 20814-4799
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Investigators
Study Director: Peter J Weina, MD, PhD Walter Reed Army Institute of Research (WRAIR)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00292929     History of Changes
Other Study ID Numbers: WRAIR 1128, USUHS G183RW, HSRRB A-13276
Study First Received: February 14, 2006
Last Updated: April 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
artesunate
artemisinin
falciparum

Additional relevant MeSH terms:
Malaria
Malaria, Cerebral
Protozoan Infections
Parasitic Diseases
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Malaria, Falciparum
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Artesunate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on April 17, 2014