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:
NCT00292942
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 multiple 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 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

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 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
  Contacts and Locations
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

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: NCT00292942     History of Changes
Other Study ID Numbers: WRAIR 1142, USUHS G183SP
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 July 24, 2014