ANZCTR - Registration

Registration number

ACTRN12610000178044

Ethics application status

Approved

Date submitted

19/02/2010

Date registered

26/02/2010

Date last updated

11/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

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)

Scientific title

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).

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anti-Malarial
Treatment of uncomplicated plasmodium falciparum malaria

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

There is no comparator or control group- all subjects receive the same active treatment- the study is comparing the pharmacokinetics across gender, body weight and asian v caucasian.

Control group

Active

Outcomes

Primary outcome [1]

To compare the pharmacokinetics of Dihydroartemisinin (DHA) and Piperaquine (PQ) between subjects grouped by ethnic
origin (i.e. Caucasian vs Asian).

This objective will be evaluated by comparison of the pharmacokinetics (PK) profile of 24 Caucasian subjects with a body
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.

Timepoint [1]

Screening: Up to 21 days prior to first dose

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)

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 [1]

To compare the pharmacokinetics of Dihydroartemisinin (DHA) and Piperaquine (PQ) between subjects grouped by body
weight (i.e. subjects below 65 kg vs subjects above 65 kg) for Caucasian subjects.
This objective will be evaluated by comparison of the pharmacokinetics (PK) profile of 24 Caucasian subjects with a body
weight of 65 kg vs the PK profile of 24 Caucasian subjects with a body weight > 65 kg and correlation
analysis between pharmacokinetics (PK) and body weight among the subjects of Caucasian origin.

Timepoint [1]

Screening: Up to 21 days prior to first dose

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)

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.

Total duration that the subject will be involved in the study (from first visit to last visit) will be approximately 16 weeks.

Secondary outcome [2]

To compare the pharmacokinetics of DHA and PQ between subjects grouped by gender.
This objective will be evaluated by comparison of the PK profile of 24 male subjects with a body
weight less than 65 kg vs the PK profile of 24 female subjects.

Timepoint [2]

Screening: Up to 21 days prior to first dose

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)

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 [3]

To compare the safety of Eurartesim between subjects grouped by dose level.

This objective will be evaluated by comparison of the incidence of adverse events, including changes
in physical examinations, vital signs, electrocardiograph (ECG) assessments and clinical laboratory tests, grouped by dose
level (3 or 4 tablets).

Timepoint [3]

Screening: Up to 21 days prior to first dose

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)

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.

Eligibility

Key inclusion criteria

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.

Minimum age

18 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

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
Final Version 3.0 of 03 Feb 2010 18/61
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

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/02/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

20

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3004

Recruitment postcode(s) [2]

5000

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Sigma-Tau i.f.r. S.p.A

Country [1]

Italy

Primary sponsor type

Commercial sector/Industry

Name

CPR Pharma Services Pty Ltd

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

CPR Pharma Services Pty Ltd

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee

Ethics committee address [1]

229 Greenhill Road
Dulwich SA 5065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/01/2010

Approval date [1]

12/02/2010

Ethics approval number [1]

C9/10

Summary

Brief 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.

Trial website

none

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Email

Contact person for public queries

Name

Tamara Murdock

Address

CPR Pharma Services Pty Ltd
Suite C, 32 West Thebarton Road
Thebarton SA 5031
Australia

Country

Australia

Phone

+61-8-8125-1906

Email

[email protected]

Contact person for scientific queries

Name

Tamara Murdock

Address

CPR Pharma Services Pty Ltd
Suite C, 32 West Thebarton Road
Thebarton SA 5031
Australia

Country

Australia

Phone

+61-8-8125-1906

Email

[email protected]

Trial Review

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Documents added automatically