Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

NCT ID: NCT01340157

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-04-30

Brief 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.

Conditions

PK in Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fasting

Treatment A: 1200mg fexinidazole administered in fasting conditions by oral route

Group Type: EXPERIMENTAL

Fexinidazole

Intervention Type: DRUG

Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.

Meal 1: Plumpy Nuts

Treatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route

Group Type: EXPERIMENTAL

Fexinidazole

Intervention Type: DRUG

Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.

Meal 2: Rice + beans

Treatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route

Group Type: EXPERIMENTAL

Fexinidazole

Intervention Type: DRUG

Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.

Interventions

Fexinidazole

Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Drugs for Neglected Diseases

OTHER

Sponsor Role: lead

Responsible Party

Drugs for Neglected Diseases Initiative

Principal Investigators

Lionel Hovsepian, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Aster

Antoine Tarral, MD

Role: STUDY_DIRECTOR

Drugs for Neglected Diseases initiative

Locations

SGS Aster s.a.s.

Paris, , France

Countries

France

Related Links

http://www.dndi.org

Sponsor website

http://www.dndi.org/wp-content/uploads/2009/06/ClinicalPK_Tarral_FexinidazoleHAT_2014.pdf

Publication combining results of NCT00982904 \& NCT01483170

Other Identifiers

DNDiFEX002

Identifier Type: -

Identifier Source: org_study_id