Safety Study on the Effect of Eurartesim™ on QT/QTc Interval Compared to Riamet in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of such a study is to evaluate the impact of a therapeutic dose of Eurartesim™ compared to Riamet®, after multiple dose administration for 3 days in healthy male and female subjects on electrocardiographic parameters.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: sigma-tau i.f.r. S.p.A.
• Collaborator: Medicines for Malaria Venture
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artenimol; Dihydroartemisinin; Fluoroquinolones; Lumefantrine; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Piperaquine

Criteria

Inclusion Criteria:

• Male or female Caucasian subject ≥ 18 and ≤ 50 years;

• Good general health (by medical history and physical examination);

• For male and female subjects of childbearing potential use a double contraception method;

• For female subjects of childbearing potential only: negative plasma pregnancy test at Screening and at admission in the clinical unit;

• Body mass index (BMI) ≥18 and ≤ 27 kg/m2;

• No clinically relevant abnormalities in blood pressure and heart rate;

• No clinically relevant abnormalities in 12-lead ECG results;

• No clinically relevant abnormalities in results of laboratory tests;

• Registered with the French Social Security in agreement with the French law on biomedical experimentation.

Exclusion Criteria:

• A predictable poor compliance or inability to communicate well with the Investigator;

• Unsuitable veins for repeated venipuncture.

• Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases as judged by the Investigator;

• A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);

• The use of concomitant medications that prolong the QT/QTc interval;

• Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study;

• Evidence of any clinically significant acute or chronic disease, including known or suspected HIV, hepatitis B virus (HBV) and HCV infection;

• History of relevant clinical allergic reactions of any origin;

• Known hypersensitivity to any of the test materials or related compounds;

• Intake of any medication (except paracetamol, hormonal contraceptives and hormone replacement therapy for postmenopausal women), including OTC medications and herbal products that could affect the outcome of the study, within 2 weeks prior to the first drug administration or less than 5 times the t1/2 of that drug, whichever is the longer;

• Drug abuse;

• Current use of nicotine containing products and the inability to stop using nicotine containing products during confinement in the clinical centre.

• Use of caffeine containing beverages exceeding 500 mg caffeine/day and the inability to refrain from the use of caffeine containing beverages during confinement in the clinical centre;

• Intake of any food or any beverage containing grapefruit or grapefruit juice, orange or pomelo juice within 48 h prior to the first dosing and the inability to stop such intake during the study;

• Blood donation or loss of significant amount of blood within three months prior to the first dosing;

• Positive drug screen;

• Positive serology to HIV (HIV1 and HIV2) and/or HCV antibodies, and/or hepatitis B surface antigen (HBsAG);

• Any other condition that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the subject;

• Participation in a drug study within 3 months prior to the first dosing.