Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

March 29, 2017 updated by: Drugs for Neglected Diseases

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • SGS Aster s.a.s.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Occurence of AEs
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drugs for Neglected Diseases

Collaborators

Sanofi

Investigators

  • Principal Investigator: Lionel Hovsepian, MD, SGS Aster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DNDiFEX002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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