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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01222949




Registration number
NCT01222949
Ethics application status
Date submitted
11/10/2010
Date registered
18/10/2010
Date last updated
18/10/2010

Titles & IDs
Public title
A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™
Scientific title
A Phase I, Pharmacokinetic Trial, in Healthy Asian and Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of Eurartesim™ (40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine (PQ) Phosphate.
Secondary ID [1] 0 0
ST3073/ST3074-DM09-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria, Falciparum 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eurartesim

Experimental: Asian Healthy Volunteers - Asian males with a body weight = 65 kg (12 subjects) Asian females with a body weight = 65 kg (12 subjects)

Experimental: Caucasian Healthy Volunteers - Caucasian males with a body weight = 65 kg (12 subjects) Caucasian females with a body weight = 65 kg (12 subjects) Caucasian males with a body weight > 65 kg (24 subjects)


Treatment: Drugs: Eurartesim
Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, ?z, t1/2
Timepoint [1] 0 0
During the first and last day of drug administration (day 0 and 2) and followed up till Day 90
Secondary outcome [1] 0 0
Number of Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From Day 0 till Day 90
Secondary outcome [2] 0 0
Hematology and blood chemistry changes respect to baseline values
Timepoint [2] 0 0
Day 0, Day 3, Day 28, Day 90
Secondary outcome [3] 0 0
QTc interval prolongation
Timepoint [3] 0 0
Day 0, day 3, day 28, day 90

Eligibility
Key inclusion criteria
- Caucasian or Asian healthy subjects, Male or female, aged between 18 and 50 years
(inclusive)

- Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body
weight of 36 kg.

- Agreed to use two approved methods of contraception

- Had 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
- Had received or was anticipated to receive a prescription medication within 14 days
prior to the start of dosing

- Pregnant or lactating (females only)

- Abnormal laboratory test results deemed clinically significant at screening

- Positive urine drug test or alcohol breath test

- Acute therapy for a serious infection within 30 days of study entry

- History of significant drug allergies or significant allergic reactions

- Had participated in a clinical trial or had received an experimental therapy within 30
days or 10 half-lives of the drug

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX, a division of IDT Australia Limited - Adelaide
Recruitment hospital [2] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
VIC 3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
sigma-tau i.f.r. S.p.A.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
CPR Pharma Services Pty Ltd, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers
and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the
relative bioavailability of DHA and PQ.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01222949
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01222949