Study of the Safety of Intravenous Artesunate

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

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

Study Overview

• Status: Completed
• Conditions: Malaria; Malaria, Cerebral
• Intervention / Treatment: Drug: Intravenous artesunate

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814-4799
      • Uniformed Services University of the Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Investigators: Study Director: Peter J Weina, MD, PhD, Walter Reed Army Institute of Research (WRAIR)

Study record dates

Study Major Dates

• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: February 14, 2006
• First Submitted That Met QC Criteria: February 14, 2006
• First Posted (Estimate): February 16, 2006

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Keywords: falciparum; artesunate; artemisinin
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Central Nervous System Parasitic Infections; Central Nervous System Protozoal Infections; Malaria; Malaria, Cerebral; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anthelmintics; Schistosomicides; Antiplatyhelmintic Agents; Artesunate
• Other Study ID Numbers: WRAIR 1128; USUHS G183RW; HSRRB A-13276