Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers

Malaria, Falciparum Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222962
• Other study ID #: ST3073/ST3074-DM09-008
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2010
• Last updated: October 14, 2010
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2010
• Source: sigma-tau i.f.r. S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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™).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria, Falciparum

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	CMAX, a division of IDT Australia Limited	Adelaide

Sponsors (2)

Lead Sponsor	Collaborator
sigma-tau i.f.r. S.p.A.	CPR Pharma Services Pty Ltd, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, ?z, t1/2, Cl/F, Vz/F [DHA].	Blood samples for determination of plasma DHA were collected at the following times: At pre-dose Day 0 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.; Blood samples for determination of plasma PQ were collected at the following times: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose; on Day 1, 2, 3, 4, 5 and 7.	from the day of study drug administration, till Day 7 follow-up	No
Secondary	Number of Treatment Emergent Adverse Events	Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period	Day 0 and till Day 30 follow-up	Yes
Secondary	Hematology and blood chemistry changes respect to baseline values	Abnormalities in hematology (Haemoglobin, Hematocrit,RBC count, White cell count and differential count, Platelets) and clinical chemistry (Protein, Sodium, Potassium, Chloride ,Total Bilirubin, Conjugated Bilirubin, Alanine Aminotransferase, Aspartate Aminotransferase, Total Cholesterol, Glucose, Bicarbonate, Urea, Urate, Lactate Dehydrogenase, Albumin, Globulins, Triglycerides, Creatinine, Alkaline Phosphatase, Gamma glutamyltransferase, Total Calcium, Phosphate, C-reactive protein) will be recorded the day of the last study drug intake and after 30 days from the start of the drug treatment	Day 0, day 2, day 30	Yes
Secondary	QTc interval prolongation	ECG recordings will be obtained at baseline, after the last drug intake and 30 days follow-up to investigate changes in ECG parameters, and specifically QTc interval changes respect to baseline	Day 0, day 2, day 30	Yes