Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

NCT01340157 | Completed Phase 1

• 1 other identifier: DNDiFEX002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Fexinidazole; Phase I; Bioavailability study; Food effect; Human African Trypanosomiasis

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (1)

• Occurence of AEs

Study Arms (3)

Fasting

EXPERIMENTAL

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

Drug: Fexinidazole

Meal 1: Plumpy Nuts

EXPERIMENTAL

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

Drug: Fexinidazole

Meal 2: Rice + beans

EXPERIMENTAL

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

Drug: Fexinidazole

Interventions

Fexinidazole DRUG

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

Fasting; Meal 1: Plumpy Nuts; Meal 2: Rice + beans

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead
• Sanofi: collaborator

Study Sites (1)

SGS Aster s.a.s.

Paris, 75015, France

Location

Related Links

• Sponsor website
• Publication combining results of NCT00982904 \& NCT01483170

MeSH Terms

Interventions

fexinidazole

Study Officials

• Lionel Hovsepian, MD

  SGS Aster

  PRINCIPAL INVESTIGATOR

• Antoine Tarral, MD

  Drugs for Neglected Diseases initiative

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 22, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 31, 2017

Record last verified: 2011-04

Locations

FR (1)