Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole

Exclusion Criteria

• •Who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV or HCV infection,
• •Who previously received fexinidazole,
• •With any clinically significant abnormality following review of pre-study laboratory tests(ASAT, ALAT and ALP must be within normal ranges), vital signs, full physical examination and ECG,
• •Who are within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health,
• •Who forfeit their freedom by administrative or legal award or who were under guardianship,
• •Unwilling to give their informed consent,
• •Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 or anti- HCV antibodies
• •Who have a history of allergy, intolerance or photosensitivity to any drug,
• •Who have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug,
• •Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol),
• •Who drink more than 8 cups daily of beverage containing caffeine,
• •Who have a positive laboratory test for urine drug screening
• •Who have undergone surgery or have donated blood within 12 weeks prior to the start of the study,
• •Who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 2 weeks prior to the first dose administration,
• •Who have any clinical condition or prior therapy which, in the opinion of the Investigator, made the subject unsuitable for the study,
• •Who participated to any clinical trial with an investigational drug in the past 3 months preceding study entry.