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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01483170
• Date of registration: 29/11/2011
• Prospective Registration: No
• Primary sponsor: Drugs for Neglected Diseases
• Public title: 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
• Scientific title: Double-blind, Placebo Controlled, Randomized Multiple Ascending Dose Study in Fed Conditions for Ten Days Dosing Regimen With a Loading Dose to Evaluate the Safety, the Tolerability and the Pharmacokinetics of Oral Fexinidazole in 36 Healthy Male Sub-Saharan Volunteers.
• Date of first enrolment: September 2011
• Target sample size: 30
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01483170
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Lionel Hovsepian, MD
• Affiliation: SGS Aster

Key inclusion & exclusion 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 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Trypanosomiasis, African

Intervention(s)

Drug: Placebo

Drug: Tablets Fexinidazole

Secondary ID(s)

DNDiFEX003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors