Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexini… (NCT00982904) | Clinical Trial Compass
CompletedPhase 1
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole
France108 participantsStarted 2009-09
Plain-language summary
This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy.
Who can participate
Age range18 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 5 cigarettes per day) or subjects who are non-smokers.
* Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator.
* 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,
* Who previously received fexinidazole,
* With any clinically significant abnormality following review of pre-study laboratory tests(ASAT, ALAT and 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…
What they're measuring
1
Occurence of adverse events (AEs)
Timeframe: 8 to 37 days, depending on the part of the study