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Hepatic Function AbnormalPhase 1NCT05607173

A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment

A Phase 1 study testing Fexinidazole (HOE239) in people with Hepatic Function Abnormal, run by Sanofi at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of the 2 active metabolites could be decreased, leading to decreased exposure in hepatic… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Function Abnormal
What is being tested?
Fexinidazole (HOE239)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesin 2 countries
Study dates
18 Jan 2023to 3 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female participants, between 18 and 75 years of age, inclusive
  • 12-lead ECG without clinically significant abnormality, in the judgment of the Investigator; normal QT interval confirmed
  • Contraception (with double contraception methods) for male and female (unless postmenopausal) participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
  • Having given written informed consent prior to any procedure related to the study
  • Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
  • Not under any administrative or legal supervision
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  • Participants with HI
  • Body weight between 50.0 and 125.0 kg, inclusive if male, and between 40.0 and 110.0 kg, inclusive if female, body mass index (BMI) between 18.00 and 34.99 kg/m2, inclusive
  • Stable chronic liver disease assessed by medical history, physical examination, laboratory values
  • Vital signs after 10 minutes resting in supine position within the following range [or if out of range, considered not clinically significant (NCS) by the Investigator]:
  • 95 mmHg < systolic blood pressure (SBP) < 180 mmHg
  • 45 mmHg < diastolic blood pressure (DBP) < 100 mmHg
  • 40 bpm < HR < 100 bpm
  • Laboratory parameters within the acceptable range for participants with HI; however, serum creatinine should be strictly below the upper laboratory normal
  • For moderate HI cohort: Child-Pugh total score ranging from 7 to 9, inclusive
  • For mild HI cohort: Child-Pugh total score ranging from 5 to 6, inclusive
  • Matched participants with normal hepatic function
  • Body weight within 15% of the mean body weight of the participants with HI to be matched, and BMI between 18.00 and 34.99 kg/m2, inclusive
  • Certified as healthy by a comprehensive clinical assessment
  • Vital signs after 10 minutes resting in the supine position within the following range:
  • 95 mmHg < SBP < 160 mmHg
  • 45 mmHg < DBP < 90 mmHg
  • 40 bpm < HR < 100 bpm
  • Laboratory parameters within the normal range, excluding specific exceptions allowed per protocol.

Who cannot join

  • Participant has clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening. Participant who had severe course of COVID-19
  • Positive test for SARS-CoV-2
  • Blood donation within 2 months before inclusion
  • Postural hypotension - symptomatic or asymptomatic (decrease in SBP ≥ 30 mmHg within 3 minutes).
  • Excessive consumption of beverages with xanthine bases
  • COVID-19 vaccination: last administration of a vaccine within 1 week (symptom free) to 2 weeks before inclusion
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  • Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development
  • Any participant in the exclusion period of a previous study according to applicable regulations
  • Any participant who cannot be contacted in case of emergency
  • Positive alcohol breath test
  • Any consumption of citrus fruits or their juices within 5 days before inclusion
  • Unable or not agreeing to self-complete the hospital anxiety and depression scale (HADS)
  • Hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
  • Positive result on anti-human immunodeficiency virus 1 and/or 2 antibodies
  • Cockayne Syndrome
  • Participants with HI
  • Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecological (if female), or infectious disease, or signs of acute illness
  • Hepatocarcinoma
  • Acute hepatitis
  • Hepatic encephalopathy grade 2, 3, and 4
  • Presence or history of drug hypersensitivity, or allergic disease, including active seasonal rhinitis, diagnosed and treated by a physician
  • History or presence of regular use of recreational drugs or alcohol abuse within 2 years before inclusion
  • Smoking more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 5 cigarettes per day from D-1 and throughout the entire institutionalization
  • Any significant change in chronic treatment medication within 14 days before inclusion
  • Consumption of CYP450 potent inducers or inhibitors that could impact the pharmacokinetics of the investigational product
  • Positive results on urine drug screen outside documented medical prescription
  • Pre-existing cardiac disease, long QT syndrome, or use of drugs known to block potassium channels, prolong the QT interval and/or induce bradycardia
  • Matched participants with normal hepatic function
  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecological (if female), or infectious disease, or signs of acute illness
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician, except seasonal rhinitis
  • History or presence of regular use of recreational drugs or alcohol abuse
  • Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking from D-1 and throughout the entire institutionalization
  • Any medication (including CYP450 inducers or inhibitors, or omeprazole) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of the medication (except HRT and contraception when applicable), any vaccination within the last 28 days (except COVID-19 vaccination) and any biologics (antibody or its derivatives) given within 4 months before inclusion
  • Positive result on any of the following tests: hepatitis B surface antigen, antihepatitis B core antibodies, anti-hepatitis C virus antibodies
  • Positive result on urine drug screen
  • The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Bulgaria1 site

  • Investigational Site Number: 100-0001

    Sofia, 1612

Other trials in Bulgaria

France1 site

  • Investigational site 250-0001

    Rennes

Other trials in France

About this study

Official title: A Multicentric, Open-label, Non-randomized, Pharmacokinetic and Tolerability Study of Fexinidazole Given as an Oral Single 1200 mg Dose in Participants With Mild and Moderate Hepatic Impairment, and in Matched Participants With Normal Hepatic Function

In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of the 2 active metabolites could be decreased, leading to decreased exposure in hepatic impairment (HI).

As there is no experience of use in patients with hepatic impairment, in fexinidazole summary of product characteristics (SmPC) approved by the European Medicines Agency (EMA), fexinidazole is contra-indicated in patients with clinical signs of cirrhosis or jaundice, and in the proposed USA product information, fexinidazole is contra-indicated in patients with liver impairment.

Therefore, FDA requested a study with the objective to evaluate the effect of mild and moderate hepatic impairment (HI) on the pharmacokinetics (PK) of fexinidazole and its 2 metabolites, as a post-marketing requirement.

Read the detailed description

The duration of the study for 1 participant will be of 38 days maximum, including:

  • A screening period from Day (D)-28 to D-2
  • Baseline assessments on D-1
  • Single dose administration on D1 and institutionalization for 6 days
  • End of study (EOS): D10, or to be organized as soon as possible in case of early withdrawal
Being tested
Fexinidazole (HOE239)
Medical subject headings
Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fexinidazole (HOE239)Drug

    Also called Fexinidazole Winthrop®

    Route of administration: oral; pharmaceutical form: tablet

Study groups in NCT05607173
Study groupRoleWhat they receive
Participants with mild HIExperimentalMild HI is defined as a total score ranging from 5 to 6, inclusive (Child-Pugh score A)
Receives: Drug: Fexinidazole (HOE239)
Participants with moderate HIExperimentalModerate HI is defined as a total score ranging from 7 to 9, inclusive (Child-Pugh score B)
Receives: Drug: Fexinidazole (HOE239)
Participants with normal hepatic functionExperimentalParticipants with normal hepatic function matched to participants
Receives: Drug: Fexinidazole (HOE239)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax for fexinidazole and metabolites M1, M2

    Maximum plasma concentration observed (Cmax)

    Measured: Day 1 to Day 6

  2. AUC for fexinidazole and metabolites M1, M2

    Area under the plasma concentration versus time curve extrapolated to infinity (AUC)

    Measured: Day 1 to Day 6

Secondary outcomes (5)

  1. tmax for fexinidazole and metabolites M1, M2

    Time to reach Cmax (tmax)

    Measured: Day 1 to Day 6

  2. Fexinidazole unbound fraction

    Measured: Day 1 and Day 2

  3. Fexinidazole unbound Cmaxu

    Unbound maximum plasma concentration observed (Cmaxu)

    Measured: Day 1 and Day 6

  4. Fexinidazole unbound AUCu

    Unbound area under the plasma concentration versus time curve extrapolated to infinity

    Measured: Day 1 and Day 6

  5. Number of subjects with Adverse Events (AEs)

    Measured: Day 1 to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start18 Jan 2023
  3. Primary completion3 May 2023
  4. Study completion3 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607173
Sponsor's protocol ID
POP17145
Other IDs
U1111-1266-5794, 2021-004580-27
Status last verified
Sep 2025
First submitted
31 Oct 2022
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fexinidazole (HOE239) in people with Hepatic Function Abnormal, run by Sanofi at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bulgaria, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax for fexinidazole and metabolites M1, M2 (time frame: Day 1 to Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05607173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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