Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole

NCT00982904 | Completed Phase 1

• 1 other identifier: DNDiFEX001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human African Trypanosomiasis

Keywords

neglected disease; africa; new drug; oral drug; parasite

Outcome Measures

Primary Outcomes (1)

• Occurence of adverse events (AEs)

  8 to 37 days, depending on the part of the study

Secondary Outcomes (1)

• Pharmacokinetic : measure of blood and urine concentration of fexinidazole, fexinidazole sulfoxide and fexinidazole sulfone in order to determine AUC0-t and Cmax values, for all dose levels

  pre-dose, and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 48, 72, 96, 120, 144 and 168 h post-dose

Study Arms (2)

Fexinidazole

EXPERIMENTAL

Drug: Fexinidazole/Placebo

Placebo

PLACEBO COMPARATOR

Drug: Fexinidazole/Placebo

Interventions

Fexinidazole/Placebo DRUG

Fexinidazole; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

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 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 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
• 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

Paris, 75015, France

Location

Related Links

• Sponsor Website
• Publication combining NCT01340157 \& NCT01483170

MeSH Terms

Conditions

Neglected Diseases

Interventions

fexinidazole

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lionel Hovsepian, MD

  SGS Aster

  PRINCIPAL INVESTIGATOR

• Nathalie Strub-Wourgaft, MD

  Drugs for Neglected Diseases initiative

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

FR (1)