Study of the Safety of Intravenous Artesunate

NCT ID: NCT00292929

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2006-10-31

Brief Summary

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

Conditions

Malaria; Malaria, Cerebral

Keywords

artesunate; artemisinin; falciparum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Intravenous artesunate

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Principal Investigators

Peter J Weina, MD, PhD

Role: STUDY_DIRECTOR

Walter Reed Army Institute of Research (WRAIR)

Locations

Uniformed Services University of the Health Sciences

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

USUHS G183RW

Identifier Type: -

Identifier Source: secondary_id

HSRRB A-13276

Identifier Type: -

Identifier Source: secondary_id

WRAIR 1128

Identifier Type: -

Identifier Source: org_study_id