Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions (NCT01340157) | Clinical Trial Compass
CompletedPhase 1
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
France12 participantsStarted 2011-02
Plain-language summary
The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.
Who can participate
Age range18 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m2) from 18 to 28 kg/m2 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 Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection,
* With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and alkaline phosphatase (ALP) must be with…
What they're measuring
1
Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions