A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™

Malaria, Falciparum Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222949
• Other study ID #: ST3073/ST3074-DM09-007
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2010
• Last updated: October 14, 2010
• Start date: February 2010
• Est. completion date: August 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

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). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.

Locations

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

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	PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, ?z, t1/2	DHA evaluation: At pre-dose on day Day 0 and Day 2 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.; PQ evaluation: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose; then at pre-dose Day 1 and Day 2 and finally at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose on day 2; on Day 3, 4, 5, 7, 14, 21, 28, 42, 56 and 90.	During the first and last day of drug administration (day 0 and 2) and followed up till Day 90	No
Secondary	Number of Treatment Emergent Adverse Events (TEAEs)	Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period	From Day 0 till Day 90	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 3, Day 28, Day 90	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 3, day 28, day 90	Yes