Study of the Safety of Intravenous Artesunate

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292929
• Other study ID #: WRAIR 1128
• Secondary ID: USUHS G183RWHSRR
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2006
• Last updated: October 25, 2016
• Est. completion date: October 2006

Study information

• Verified date: March 2007
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Cerebral

Intervention

Drug:
• Intravenous artesunate

Locations

Country	Name	City	State
United States	Uniformed Services University of the Health Sciences	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States,