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)
A phase 1 pharmacokinetic trial in healthy Asian and Caucasian volunteers, investigating the pharmacokinetic profile of an Anti-Malarial drug - 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP).
CPR Pharma Services Pty Ltd
20 participants
Feb 15, 2010
Interventional
Conditions
Summary
The purpose of this study is to test the safety of the drug Eurartesim (trademarked). The drug is to be used for the treatment of uncomplicated Plasmodium Falciparum (a type of malaria, a mosquito borne infectious disease). A number of safety studies have been completed for this new drug, but the company requires more information about what happens when taking this drug in certain groups of people, including the differences between men and women, and the differences between asian and caucasian (western) people and the difference in body weights ( particularly people weighing less than 65 kg and those weighing more than 65kg). The study is to be conducted in helathy people to comapre how the drug behaves in these groups.
Eligibility
Inclusion Criteria18
- Male or female, aged between 18 and 50 years (inclusive).
- Caucasian or Asian (excluding Indian sub-continent or Middle Eastern origin).
- 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.
- Adequate venous access in the left or right arm to allow collection of a number of blood
- samples.
- Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum
- body weight of 36 kg.
- 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).
- Have given written informed consent to participate in this study in accordance with local
- regulations.
Exclusion Criteria30
- 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.
- Any condition that would interfere with drug absorption (e.g. chronic diarrhoea).
- ST3073/ST3074-DM09-007
- Final Version 3.0 of 03 Feb 2010 18/61
- Be pregnant or lactating (females only).
- Abnormal laboratory test results deemed clinically significant by the Medical Officer
- (Principal Investigator or medically qualified nominee).
- 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.
- 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.
- Positive urine drug test or alcohol breath test.
- 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.
- Acute therapy for a serious infection within 30 days of study entry.
- History of significant drug allergies or significant allergic reaction or currently suffers from
- clinically significant systemic allergic disease.
- Positive Screening test for Hepatitis B surface antigen or Hepatitis C antibody or HIV
- (human immunodeficiency virus).
- 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.
- Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within
- days before the first dose administration.
- 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).
- Unwilling to abide by the study restrictions listed in Section 8.3, including refraining from
- smoking during the confinement period.
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Interventions
Eurartesim (trademark) is a fixed dose combination tablet for oral administration. Each tablet contains 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP) On the study each subject recieves either three or four tablets daily for three consecutive days. The tablets are to be administered following a light breakfast (30 g cornflakes and 250 mL fullfat milk). The number of tablets administered is calculated using the subjects body weight - subjects weighing less than 75 kg are prescribed three tablets and subjects weighing greater than 75 kg are prescribed four tablets.
Locations(1)
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ACTRN12610000178044