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
  Purpose

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.


Condition Intervention Phase
Malaria, Falciparum
Drug: Eurartesim
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by sigma-tau i.f.r. S.p.A.:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Enrollment: 80
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asian Healthy Volunteers
Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)
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: 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222949

Locations
Australia
CMAX, a division of IDT Australia Limited
Adelaide, Australia, SA 5000
Nucleus Network Limited
Melbourne, Australia, VIC 3004
Sponsors and Collaborators
sigma-tau i.f.r. S.p.A.
CPR Pharma Services Pty Ltd, Australia
  More Information

No publications provided

Responsible Party: Giovanni Valentini, MD, Medical Department, R&D Division, Sigma-Tau ifr SpA
ClinicalTrials.gov Identifier: NCT01222949     History of Changes
Other Study ID Numbers: ST3073/ST3074-DM09-007
Study First Received: October 11, 2010
Last Updated: October 14, 2010
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Malaria, Falciparum
Malaria
Protozoan Infections
Parasitic Diseases
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014