A Phase 1 interventional study of Fexinidazole in Trypanosomiasis, African, sponsored by Drugs for Neglected Diseases. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-08.
Sponsored by Drugs for Neglected Diseases · Phase 1 and Interventional
Among 16 studies in Trypanosomiasis, African by Drugs for Neglected Diseases — 1 open to participants now, 1 under way, 1 of them phase 3. Trypanosomiasis, African · Drugs for Neglected Diseases.
Among the 16 studies in Trypanosomiasis, African by Drugs for Neglected Diseases, this one is the 13th largest by enrollment, is the only one that started in 2015, is one of 5 in phase 1, and was the 8th registered.
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 →1 of the 16 studies in Trypanosomiasis, African by Drugs for Neglected Diseases is open now.
16 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2015.
Median enrollment 155 across the 16 interventional studies. Of the 15 that completed or were terminated, 4 (27%) have results posted.
Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
1 of the studies in Trypanosomiasis, African by Drugs for Neglected Diseases that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06356974Phase 3Drugs for Neglected DiseasesStop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT) | 2026-12-30 |
Among the 16 studies in Trypanosomiasis, African by Drugs for Neglected Diseases, from their registry updates:
Nothing recorded among them since 2026-09-25.
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition.
The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate crossover study under fed condition. The 4-period sequences for the replicate design will be TRTR and RTRT, where R designates the reference formulation and T the test formulation. Subject will be allocated randomly to one of the two sequences of treatments according to the randomization list.
Ideally, BE study should be conducted under fasting condition as this is considered to be the most sensitive condition to detect a potential difference between formulations. However as fexinidazole is recommended to be taken with food, as food increased the plasma concentration by 2.5 to 3 fold compared to plasma. BE will be conducted under fed condition, using field adapted meal. The wash-out period should be sufficient to ensure that drug concentrations are below the limit of quantification in all the subjects at the beginning of the next period, a 2 weeks wash-out period will be used. The intra-subject variability of fexinidazole was evaluated based on a previous 3-period cross-over study (1) and was estimated at 25%. As this value was quite high and close to 30%, a replicate design was chosen.
Primary objective:
To assess BE of the clinical trial 600 mg tablet formulation versus (vs.) the proposed market 600 mg tablet formulation of fexinidazole under fed condition after single oral administration of 1200 mg.
Secondary objectives:
To assess the pharmacokinetic profile of the two metabolites fexinidazole sulfoxide and fexinidazole sulfone under the fed condition. To assess the safety and tolerability in healthy volunteers under the same study conditions.
Meal: On each treatment period, fexinidazole will be given with concomitant meal which composition will be as close as possible to field condition
sample size: In order to have 24 evaluable subjects a total of 30 subjects will be recruited in the study.
Study Treatment: Single oral dose of 1200 mg / period :
Pharmacokinetic sampling: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120 and 168 h post-dose Total blood drawn: 390 mL ( Pharmacokinetic = 240 mL + safety = 150 mL)
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.
Exclusion Criteria:
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.
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.
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.
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.
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 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 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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
crossover design
Drug: Fexinidazole
crossover design
Drug: Fexinidazole
Pharmacokinetic parameters of fexinidazole following single dose
Area Under the Curve (AUC)
Time frame: Pharmacokinetic sampling: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120 and 168 h
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fexinidazole
Drugs for Neglected Diseases