Clinical trial NCT00292929: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Malaria, Cerebral
Keywords: artesunate
artemisinin
falciparum
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2006-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: Peter J Weina, MD, PhD
role: STUDY_DIRECTOR
References: