Overview

Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Drugs for Neglected Diseases
Collaborator:
Sanofi
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 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 within normal ranges), vital signs, full physical
examination and Electrocardiogram (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.