Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT01340157
First received: April 14, 2011
Last updated: April 27, 2011
Last verified: April 2011
  Purpose

The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.


Condition Intervention Phase
PK in Healthy Volunteers
Drug: Fexinidazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Randomized, Open Study to Assess the Impact of Two Different Types of Food on the Relative Bioavailability of Fexinidazole Tablets After Single Oral Dose in Healthy Male Volunteers

Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurence of AEs [ Designated as safety issue: Yes ]
    To assess safety and tolerability of fexinidazole tablets administered as single oral dose under fasting conditions and after two different meals in healthy male volunteers.


Enrollment: 12
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasting
Treatment A: 1200mg fexinidazole administered in fasting conditions by oral route
Drug: Fexinidazole
Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.
Experimental: Meal 1: Plumpy Nuts
Treatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route
Drug: Fexinidazole
Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.
Experimental: Meal 2: Rice + beans
Treatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route
Drug: Fexinidazole
Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340157

Locations
France
SGS Aster s.a.s.
Paris, France, 75015
Sponsors and Collaborators
Drugs for Neglected Diseases
Sanofi
Investigators
Principal Investigator: Lionel Hovsepian, MD SGS Aster
Study Director: Antoine Tarral, MD Drugs for Neglected Diseases Initiative
  More Information

Additional Information:
No publications provided

Responsible Party: Antoine Tarral, MD, Drugs for Neglected Diseases Initiative
ClinicalTrials.gov Identifier: NCT01340157     History of Changes
Other Study ID Numbers: DNDiFEX002
Study First Received: April 14, 2011
Last Updated: April 27, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Drugs for Neglected Diseases:
Fexinidazole
Phase I
Bioavailability study
Food effect
Human African Trypanosomiasis

ClinicalTrials.gov processed this record on April 17, 2014