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

Primary Purpose

Malaria, Falciparum

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Eurartesim
Sponsored by
sigma-tau i.f.r. S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria, Falciparum

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CMAX, a division of IDT Australia Limited
  • Nucleus Network Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Asian Healthy Volunteers

Caucasian Healthy Volunteers

Arm Description

Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)

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)

Outcomes

Primary Outcome Measures

PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, 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.

Secondary Outcome Measures

Number of Treatment Emergent Adverse Events (TEAEs)
Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period
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
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

Full Information

First Posted
October 11, 2010
Last Updated
October 14, 2010
Sponsor
sigma-tau i.f.r. S.p.A.
Collaborators
CPR Pharma Services Pty Ltd, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01222949
Brief Title
A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
sigma-tau i.f.r. S.p.A.
Collaborators
CPR Pharma Services Pty Ltd, Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asian Healthy Volunteers
Arm Type
Experimental
Arm Description
Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)
Arm Title
Caucasian Healthy Volunteers
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Eurartesim
Intervention Description
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.
Primary Outcome Measure Information:
Title
PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2
Description
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.
Time Frame
During the first and last day of drug administration (day 0 and 2) and followed up till Day 90
Secondary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Description
Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period
Time Frame
From Day 0 till Day 90
Title
Hematology and blood chemistry changes respect to baseline values
Description
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
Time Frame
Day 0, Day 3, Day 28, Day 90
Title
QTc interval prolongation
Description
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
Time Frame
Day 0, day 3, day 28, day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CMAX, a division of IDT Australia Limited
City
Adelaide
ZIP/Postal Code
SA 5000
Country
Australia
Facility Name
Nucleus Network Limited
City
Melbourne
ZIP/Postal Code
VIC 3004
Country
Australia

12. IPD Sharing Statement

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

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