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Study of the Safety of Intravenous Artesunate

Primary Purpose

Malaria, Malaria, Cerebral

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous artesunate
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring artesunate, artemisinin, falciparum

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Uniformed Services University of the Health Sciences

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2006
Last Updated
October 25, 2016
Sponsor
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT00292929
Brief Title
Study of the Safety of Intravenous Artesunate
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
U.S. Army Medical Research and Development Command

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Malaria, Cerebral
Keywords
artesunate, artemisinin, falciparum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intravenous artesunate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Weina, MD, PhD
Organizational Affiliation
Walter Reed Army Institute of Research (WRAIR)
Official's Role
Study Director
Facility Information:
Facility Name
Uniformed Services University of the Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814-4799
Country
United States

12. IPD Sharing Statement

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