A Phase I, pharmacokinetic trial, in healthy Asian and Caucasian volunteers for investigating the pharmacokinetic profiles of Eurartesim (trademark) (40 mg Dihydroartemisinin/320 mg Piperaquine Phosphate)
- Conditions
- Anti-MalarialTreatment of uncomplicated plasmodium falciparum malariaAnti-MalarialTreatment of uncomplicated plasmodium falciparum malariaInfection - Other infectious diseases
- Registration Number
- ACTRN12610000178044
- Lead Sponsor
- CPR Pharma Services Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Male or female, aged between 18 and 50 years (inclusive).
2. Caucasian or Asian (excluding Indian sub-continent or Middle Eastern origin).
3. Healthy subjects - healthy subjects are defined as individuals who are free from clinically
significant illness or disease as determined by their medical/surgical history, physical
examination (including height and weight), vital signs, 12-lead ECG and clinical laboratory
determinations.
4. Adequate venous access in the left or right arm to allow collection of a number of blood
samples.
5. Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum
body weight of 36 kg.
6. Agrees to use two approved methods of contraception (excluding post menopausal females
and males and females who underwent surgical sterilization at least six months prior to
dosing) from Screening and until 90 days after administration of the study drug. Methods
of contraception for use by the subject or partner (as applicable) may include condom,
approved birth control pills, patches, implants or injections, diaphragm with vaginal
spermacide, an IUD (intra uterine device).
7. Have given written informed consent to participate in this study in accordance with local
regulations.
1. Have received or is anticipated to receive a prescription medication within 14 days prior to
the start of dosing or an over-the-counter medicine 48 hours prior to the start of dosing.
2. Any condition that would interfere with drug absorption (e.g. chronic diarrhoea).
ST3073/ST3074-DM09-007
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3. Be pregnant or lactating (females only).
4. Abnormal laboratory test results deemed clinically significant by the Medical Officer
(Principal Investigator or medically qualified nominee).
5. Evidence of significant renal insufficiency, as indicated by an estimated creatinine
clearance using the Cockcroft-Gault formula of less than 75 mL/min at Screening.
6. As a result of medical review, physical examination (including height and weight) or
Screening investigations, the Medical Officer considers the subject unfit for the study.
7. Positive urine drug test or alcohol breath test.
8. History or clinical evidence of oral, cardiovascular, cerebrovascular, haematological,
gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric or skin
disorder, which in the opinion of the Investigator would compromise the participant’s
safety or other aspects of the study.
9. Acute therapy for a serious infection within 30 days of study entry.
10. History of significant drug allergies or significant allergic reaction or currently suffers from
clinically significant systemic allergic disease.
11. Positive Screening test for Hepatitis B surface antigen or Hepatitis C antibody or HIV
(human immunodeficiency virus).
12. Have participated in a clinical trial or have received an experimental therapy within 30
days or 10 half-lives of the drug, whichever is the longer, prior to dosing.
13. Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within
90 days before the first dose administration.
14. Regularly drink more than four (4) units (for males) and two (2) units (for females) of
alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit).
15. Unwilling to abide by the study restrictions listed in Section 8.3, including refraining from
smoking during the confinement period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pharmacokinetics of Dihydroartemisinin (DHA) and Piperaquine (PQ) between subjects grouped by ethnic<br>origin (i.e. Caucasian vs Asian).<br><br>This objective will be evaluated by comparison of the pharmacokinetics (PK) profile of 24 Caucasian subjects with a body<br>weight of less than or equal to 65 kg vs the pharmacokinetics (PK) profile of 24 Asian subjects with a body weight of less than or equal to 65 kg.[Screening: Up to 21 days prior to first dose<br><br>Dosing Period: Subjects are confined to the clincial unit from the evening of Day -1 to the evening of Day 3, and will receive dosing on Days 0, 1 and 2. (Days are calculated as Day -1, Day 0, Day 1,2,3 etc)<br><br>Follow-up Period: Subjects are to return to the clinical unit on the following days for the collection of pharmacokinetic samples and saftey checks- Days 4,5,7,14,21,28,42,56 and 90.]
- Secondary Outcome Measures
Name Time Method