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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/NCT01222962




Registration number
NCT01222962
Ethics application status
Date submitted
11/10/2010
Date registered
18/10/2010
Date last updated
18/10/2010

Titles & IDs
Public title
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers
Scientific title
Study of the Effect of Food on the Pharmacokinetics of DHA and PQP After Single Oral Administration of Eurartesim™ in Healthy Male Adult Volunteers
Secondary ID [1] 0 0
ST3073/ST3074-DM09-008
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: fed treatment - 18 healthy volunteers administered with a single dose of Eurartesim

Experimental: Fasted Treatment - 18 healthy volunteers treated with a single dose of Eurartesim


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

Outcomes
Primary outcome [1] 0 0
tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, ?z, t1/2, Cl/F, Vz/F [DHA].
Timepoint [1] 0 0
from the day of study drug administration, till Day 7 follow-up
Secondary outcome [1] 0 0
Number of Treatment Emergent Adverse Events
Timepoint [1] 0 0
Day 0 and till Day 30 follow-up
Secondary outcome [2] 0 0
Hematology and blood chemistry changes respect to baseline values
Timepoint [2] 0 0
Day 0, day 2, day 30
Secondary outcome [3] 0 0
QTc interval prolongation
Timepoint [3] 0 0
Day 0, day 2, day 30

Eligibility
Key inclusion criteria
- Caucasian healthy males 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 75 kg.

- Agreed to use two approved methods of contraception from Screening and until 90 days
after administration of the study drug

- Had given written informed consent to participate in this study in accordance with
local regulations.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
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 or an over-the-counter medicine 48 hours prior to the
start of dosing.

- Abnormal laboratory test results deemed clinically significant by the Medical Officer.

- Positive urine drug test (e.g. opiates and cannabinoids) or alcohol breath test.

- History of significant drug allergies or significant allergic reaction.

- 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
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX, a division of IDT Australia Limited - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide

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 assess the effect of food on the extent and rate of absorption of
Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose
combination (Eurartesim™).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01222962
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/NCT01222962