Status:
TERMINATED
Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Trypanosomiasis, African
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-s...
Detailed Description
Objectives: Primary Objectives: To assess safety and tolerability of two different fexinidazole dosing regimen, for 10 days repeated administration under fed conditions in healthy male sub-Saharan vo...
Eligibility Criteria
Inclusion
- 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 m)2 from 18 to 28 kg/m2 inclusive 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
- Who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV or HCV infection,
- With any clinically significant abnormality following review of pre-study laboratory tests(ASAT, ALAT and alkaline phosphatase (ALP) must be within normal ranges), vital signs, full physical examination and 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01483170
Start Date
September 1 2011
End Date
February 1 2012
Last Update
March 31 2017
Active Locations (1)
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1
SGS Life Sciences
Paris, France, 75015