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

This study has been completed.
Sponsor:
Collaborator:
CPR Pharma Services Pty Ltd, Australia
Information provided by:
sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:
NCT01222949
First received: October 11, 2010
Last updated: October 14, 2010
Last verified: October 2010

October 11, 2010
October 14, 2010
February 2010
July 2010   (final data collection date for primary outcome measure)
PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2 [ Time Frame: During the first and last day of drug administration (day 0 and 2) and followed up till Day 90 ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01222949 on ClinicalTrials.gov Archive Site
  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Day 0 till Day 90 ] [ Designated as safety issue: Yes ]
    Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period
  • Hematology and blood chemistry changes respect to baseline values [ Time Frame: Day 0, Day 3, Day 28, Day 90 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 0, day 3, day 28, day 90 ] [ Designated as safety issue: Yes ]
    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
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria, Falciparum
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.
  • Experimental: Asian Healthy Volunteers
    Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)
    Intervention: Drug: Eurartesim
  • Experimental: Caucasian Healthy Volunteers
    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: Drug: Eurartesim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01222949
ST3073/ST3074-DM09-007
No
Giovanni Valentini, MD, Medical Department, R&D Division, Sigma-Tau ifr SpA
sigma-tau i.f.r. S.p.A.
CPR Pharma Services Pty Ltd, Australia
Not Provided
sigma-tau i.f.r. S.p.A.
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP