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Completed

NCT Number: NCT01222962

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

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™).

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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

Male

Study type

Interventional

Phase

Phase 1

Primary location

CMAX, a division of IDT Australia Limited

Adelaide, SA 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Eurartesim

Drug

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 outcomes

  1. tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, t1/2, Cl/F, Vz/F [DHA].

    Time frame: from the day of study drug administration, till Day 7 follow-up

    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 outcomes

  1. Number of Treatment Emergent Adverse Events

    Time frame: Day 0 and till Day 30 follow-up

    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 2, day 30

    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 2, day 30

    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

Study of the Effect of Food on the Pharmacokinetics of DHA and PQP After Single Oral Administration of Eurartesim™ in Healthy Male Adult Volunteers

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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