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Completed

NCT Number: NCT01222949

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

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.

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Key information

Conditions

Malaria, Falciparum Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX, a division of IDT Australia Limited, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eurartesim

Drug

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 outcomes

  1. 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

    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 outcomes

  1. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From Day 0 till Day 90

    Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period

  2. Hematology and blood chemistry changes respect to baseline values

    Time frame: Day 0, Day 3, Day 28, Day 90

    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

  3. QTc interval prolongation

    Time frame: Day 0, day 3, day 28, day 90

    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

Sponsors and collaborators

Lead sponsor

sigma-tau i.f.r. S.p.A.

Industry

Collaborators

  • CPR Pharma Services Pty Ltd, Australia

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 18, 2010
Registry last updated
Oct 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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