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

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)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • CMAX, a division of IDT Australia Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

fed treatment

Fasted Treatment

Arm Description

18 healthy volunteers administered with a single dose of Eurartesim

18 healthy volunteers treated with a single dose of Eurartesim

Outcomes

Primary Outcome Measures

tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, 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.

Secondary Outcome Measures

Number of Treatment Emergent Adverse Events
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
NCT01222962
Brief Title
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 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 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™).

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
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fed treatment
Arm Type
Experimental
Arm Description
18 healthy volunteers administered with a single dose of Eurartesim
Arm Title
Fasted Treatment
Arm Type
Experimental
Arm Description
18 healthy volunteers treated with a single dose of Eurartesim
Intervention Type
Drug
Intervention Name(s)
Eurartesim
Intervention Description
Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.
Primary Outcome Measure Information:
Title
tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, t1/2, Cl/F, Vz/F [DHA].
Description
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.
Time Frame
from the day of study drug administration, till Day 7 follow-up
Secondary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events
Description
Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period
Time Frame
Day 0 and till Day 30 follow-up
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 2, day 30
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 2, day 30

10. Eligibility

Sex
Male
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 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.
Facility Information:
Facility Name
CMAX, a division of IDT Australia Limited
City
Adelaide
ZIP/Postal Code
SA 5000
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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