Study of the Safety of Intravenous Artesunate

Overview

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

Full Title of Study: “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

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

Interventions

  • Drug: Intravenous artesunate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

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

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