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

Primary Purpose

Human African Trypanosomiasis

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Fexinidazole/Placebo

About this trial

This is an interventional treatment trial for Human African Trypanosomiasis focused on measuring neglected disease, africa, new drug, oral drug, parasite

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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 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.

Sites / Locations

SGS Aster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fexinidazole

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Occurence of adverse events (AEs)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00982904

First Posted

September 22, 2009

Last Updated

April 5, 2017

Sponsor

Drugs for Neglected Diseases

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00982904

Brief Title

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

Official Title

Randomized, Double-blind, Placebo-controlled Study of the Tolerability, and Pharmacokinetics of Fexinidazole After Single and Repeated Oral Ascending Doses, Completed by a Comparative Bioavailability Study of an Oral Suspension Versus a Tablet and an Exploratory Assessment of Food Effect, in Healthy Male Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Drugs for Neglected Diseases

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The present study is designed to obtain safety, tolerability and PK data after single and multiple oral administration of increasing doses of fexinidazole in healthy male sub-Saharan African subjects. This study will also assess the relative bioavailability of fexinidazole administered as a tablet in comparison with oral suspension, and to assess the impact of concomitant food intake on the relative bioavailability of fexinidazole after single oral dose administration. The study will be divided in 3 successive parts. Study Part I will be a randomized, double-blind, placebo-controlled, single ascending dose study with fexinidazole administered as an oral suspension. Study Part II will be a comparative bioavailability study of a fexinidazole tablet vs. the oral suspension and assessment of food effect, according to a three-way cross-over design. Clinical part will be conducted in open conditions and bioanalysis in blind conditions. Study Part III will be a randomized, double-blind, placebo-controlled, multiple ascending dose study with fexinidazole administered either as an oral suspension or as a tablet, depending on Part II results. Dosage regimen will be either q.d. or b.i.d., depending on Part I and Part II results for the unchanged drug and the metabolites. Treatment duration will be 14 days. Bioanalysis will be performed in open conditions for Study Part I and Study Part III.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human African Trypanosomiasis

Keywords

neglected disease, africa, new drug, oral drug, parasite

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fexinidazole

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fexinidazole/Placebo

Primary Outcome Measure Information:

Title

Occurence of adverse events (AEs)

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lionel Hovsepian, MD

Organizational Affiliation

SGS Aster

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nathalie Strub-Wourgaft, MD

Organizational Affiliation

Drugs for Neglected Diseases initiative

Official's Role

Study Chair

Facility Information:

Facility Name

SGS Aster

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Links:

URL

http://www.dndi.org

Description

Sponsor Website

URL

http://www.dndi.org/wp-content/uploads/2009/06/ClinicalPK_Tarral_FexinidazoleHAT_2014.pdf

Description

Publication combining NCT01340157 & NCT01483170

Available IPD and Supporting Information:

Available IPD/Information Type

Publication of results

Available IPD/Information URL

http://www.dndi.org/wp-content/uploads/2009/06/ClinicalPK_Tarral_FexinidazoleHAT_2014.pdf

Available IPD/Information Comments

Publication of results

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

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