Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days.

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

Details

• Lead Sponsor: Drugs for Neglected Diseases

Criteria

Inclusion Criteria:

• Male healthy volunteers 18 to 45 years of age,

• All subjects to be of sub-Saharan African origins with both parents of sub-Saharan African origins too,

• Male subjects with a body mass index (BMI) calculated as weight in kg/(height in m)2 from 18 to 28 kg/m2 inclusive at screening,

• Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study,

• Provision of written informed consent to participate as shown by a signature on the volunteer consent form,

• Light smokers (less than 10 cigarettes per day) or subjects who are non-smokers. No smoking (or use of smoking substitute e.g. nicotine patch) is permitted from screening throughout the study,

• Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator. These will be measured after resting for 5 min,

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

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,

• With any clinically significant abnormality following review of pre-study laboratory tests(ASAT, ALAT and alkaline phosphatase (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 (opiates, cocaine,amphetamine, cannabis, benzodiazepines),

• 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.