TerminatedNCT01483170Updated Mar 31, 2017

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

A Phase 1 interventional study of Tablets Fexinidazole and Placebo in Trypanosomiasis, African, sponsored by Drugs for Neglected Diseases. Terminated at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-31.

Sponsored by Drugs for Neglected Diseases · Phase 1, Interventional, and Treatment

Why this study was terminated

poor tolerability at highest dose

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study 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-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days.

Read the 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 volunteers.

Secondary objectives: To validate the exposure to fexinidazole, M1 and M2 after different dosing regimens in fed conditions for 10 days in order to evaluate the more appropriate administration regimen for the pivotal phase II/III study.

Methodology/Study Design:

Two dose regimens consisting of repeated oral ascending dose (OAD) dosing in fed condition with two different ascending loading doses for 4 days followed by the same dose for 6 days will be evaluated. The study will be conducted in double-blind conditions for both the clinical and bioanalytical parts.

For each dosing regimen, subjects will reside at the clinical unit from the evening of Day -2 to the afternoon of Day 17 including an 8 days safety follow up (168 h post last dose).

Conditions studied

Trypanosomiasis, African

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In context

Trypanosomiasis, African

26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.

This study's enrollment of 30 is below the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.

Browse Trypanosomiasis, African studies →

Lead sponsor

Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 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 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

Exclusion Criteria:

Who on direct questioning and physical examination have evidence of any acute or chronic disease, including known or suspected , or 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 ,
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 ,
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 drug in the past 3 months preceding study entry.

Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Experimental
Fexinidazole
Drug: Tablets Fexinidazole
Placebo comparator
Placebo fexinidazole
Drug: Placebo

Interventions

DrugTablets Fexinidazole
Administration of 3 or 4 tablets of 600mg per day during 4 days (loading dose) then administration of 2 tablets of 600mg for 6 days Dosing in fed condition.
DrugPlacebo
Placebo fexinidazole

Study locations

1 site

SGS Life Sciences
Paris, 75015, France

References and documents

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2011, a primary completion of Dec 2011 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 29, 2011
First posted: Dec 1, 2011
Start: Sep 2011
Primary completionActual: Dec 2011
CompletionActual: Feb 2012
Last update: Mar 31, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01483170
Lead sponsor: Drugs for Neglected Diseases
Responsible party: Sponsor
First posted: Dec 1, 2011
Start date: Sep 2011
Primary completion: Dec 2011
Completion: Feb 2012
Last update: Mar 31, 2017

Study contacts

Lionel Hovsepian, MD

principal investigator · SGS Aster

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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