Acute-on-Chronic Liver FailurePhase 1NCT07110441
Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers
A Phase 1 study testing Single Dose G1090N and Multiple dosing of G1090N in people with Acute-on-Chronic Liver Failure, run by Genfit at 1 site in United States.
Trial summary
A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute-on-Chronic Liver Failure
- What is being tested?
- Single Dose G1090N and Multiple dosing of G1090N
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 3 Dec 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy subjects with absence of clinically relevant abnormalities as determined by the Investigator or medically qualified designee based on a detailed medical history and complete physical examination;
- 2. Clinical laboratory test results for liver and renal function within the normal reference range. For all other clinical laboratory parameters, results outside the normal reference range to be confirmed by the Investigator and the Sponsor as not clinically significant;
- 3. Male or female subjects ≥18 and ≤55 years of age with a minimum body weight of 50 kg and a body mass index of ≥18.0 to ≤30.0 kg/m2 at the time of signing the informed consent form (ICF);
- 4. Subjects willing and able to comprehend and sign informed consent and to comply with the requirements of this study.
Who cannot join
- 1. Significant history or clinical manifestation of any metabolic (including thyroid), allergic, dermatological, hepatic (including Gilbert's syndrome), renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal, neurological, or psychiatric disorder;
- 2. Experienced an acute illness within 14 days of SCR;
- 3. Positive serologic test for hepatitis B surface antigen, or for hepatitis C virus antibody, or human immunodeficiency virus I and II at SCR; positive coronavirus disease 2019 test at Day -1 of Part 1 or Part 2;
- 4. Frequent headaches (more than twice a month) and/or migraines, recurrent nausea and/or vomiting, or diarrhea;
- 5. Smokers, defined as having used tobacco- or nicotine-containing products within 6 months prior to SCR;
- 6. Out-of-range vital signs at rest (ie, supine for at least 5 minutes) at SCR and Day -1 of Part 1 and Part 2, defined as:
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- Systolic blood pressure (SBP) <90 mm Hg or >140 mm Hg;
- Diastolic blood pressure (DBP) <50 mm Hg or >90 mm Hg;
- Pulse rate <50 bpm or >90 bpm; For these parameters, out-of-range values that are not clinically significant (as determined by the Investigator) may be repeated twice during SCR and the subject may be enrolled if at least one repeated value is within the range noted above;
- 7. Symptomatic hypotension at SCR, regardless of the decrease of blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP ≥20 mm Hg or DBP ≥10 mm Hg within 3 minutes when changing from the supine to the standing position;
- 8. Out-of-range 12-lead electrocardiogram (ECG) recordings at SCR defined as:
- PR ≤120 ms or ≥220 ms;
- QRS >120 ms;
- QT interval corrected for heart rate using Fridericia's method ≥450 ms; For these parameters, out-of-range values that are not clinically significant (as determined by the Investigator) may be repeated twice during SCR and Day -1 and the subject may be enrolled if at least 1 repeated value is within the normal ranges noted above; Subjects must also have no sign of any clinically significant irregularity in heart rhythm.
- 9. Use of any prescription or nonprescription drugs or substances (including vitamins and dietary or herbal supplements) within 30 days or 5 half-lives, if known, of the respective drug or substance, whichever is longer, prior to investigational medicinal product (IMP) administration, unless deemed acceptable by the Investigator and Sponsor;
- 10. Vaccination with a live vaccine within 6 months prior to first dosing or vaccination with an inactivated vaccine (eg, inactivated influenza vaccines or severe acute respiratory syndrome coronavirus 2 vaccines) within 30 days prior to first dosing;
- 11. Receipt of NTZ, or any investigational product within 30 days, or 5 half-lives, if known, of the respective investigational product, whichever is longer, prior to SCR;
- 12. History of alcohol consumption defined as >30 g pure alcohol/day for men, and >20 g pure alcohol/day for women within the last year, or any alcohol consumption within 48 hours prior to SCR or Day -1 for Part 1 and Part 2;
- 13. Consumption of caffeine- or xanthine-containing products (>4 cups or glasses per day of eg, coffee, tea, cola drinks, and chocolate) within 48 hours prior to SCR or Day -1 for Part 1 and Part 2;
- 14. Subjects following a vegan or vegetarian diet or any other dietary restrictions;
- 15. Strenuous exercise within 24 hours prior to SCR or Day -1 for Part 1 and Part 2;
- 16. Blood donation or blood loss (excluding volume drawn at SCR) of 50 to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to IMP administration;
- 17. Receipt of blood products within 2 months prior to SCR;
- 18. History of a major surgical procedure within 6 months prior to SCR. (NOTE: subjects may have had a cholecystectomy, provided not within 3 months of SCR and no complications with cholecystectomy);
- 19. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (eg, bariatric-metabolic surgery, etc.);
- 20. Poor peripheral venous access;
- 21. Known hypersensitivity to the IMP or any of its formulation excipients;
- 22. History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the subject at undue risk;
- 23. Pregnancy or lactation;
- 24. Women of childbearing potential and non-sterile men who are not willing to use adequate contraception for the full duration of the study and for 90 days after the last dose of IMP.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: A Phase 1, Open Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects
A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects
- Conditions
- Acute-on-Chronic Liver Failure
- Being tested
- Single Dose G1090N, Multiple dosing of G1090N
- Keywords
- Acute-on-Chronic Liver Failure; ACLF; G1090N, Tizoxanide, Nitazoxanide, Pharmacokinetics, Healthy volunteer
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Dose G1090NDrug
Subjects will receive single ascending doses of G1090N up to 1200mg.
Multiple dosing of G1090NDrug
Subjects will receive multiple ascending doses of G1090N up to 1200mg twice daily for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| G1090N 300 mg | Experimental | Subjects will recieve a single dose of G1090N Receives: Drug: Single Dose G1090N |
| G1090N 600 mg | Experimental | Subjects will recieve single and multiple doses of G1090N Receives: Drug: Single Dose G1090N; Drug: Multiple dosing of G1090N |
| G1090N 900 mg | Experimental | Subjects will recieve single and multiple doses of G1090N Receives: Drug: Single Dose G1090N; Drug: Multiple dosing of G1090N |
| G1090N 1200 mg | Experimental | Subjects will recieve single and multiple doses of G1090N Receives: Drug: Single Dose G1090N; Drug: Multiple dosing of G1090N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax)
To evaluate pharmacokinetics (PK) following single and multiple ascending dose administration of G1090N in healthy subjects.
Plasma PK parameters will be determined for tizoxanide (TZ) and tizoxanide glucuronide (TZG) concentrations including but not limited to Cmax.
Measured: Up to Day 9
Time to Cmax (tmax)
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects.
Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to tmax.
Measured: Up to Day 9
Area under the plasma concentration-time curve (AUC)
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects.
Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to AUC.
Measured: Up to Day 9
Terminal half-life (t1/2)
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects.
Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to t1/2.
Measured: Up to Day 9
Amount excreted (Ae)
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects.
Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to Ae.
Measured: Up to Day 8
Renal clearance (CLr)
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects.
Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to CLr.
Measured: Up to Day 8
Fraction of dose excreted (fe)
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects.
Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to fe.
Measured: Up to Day 8
Secondary outcomes (1)
To evaluate safety and tolerability following single and multiple ascending dose administration of G1090N in healthy subjects
Observed values and change from baseline, when relevant, for clinical laboratory safety parameters, vital signs measurements, 12-lead ECG parameters, and physical examinations.
Safety and tolerability defined as the incidence and severity (NCI CTCAE v5.0 grade) of TEAEs including SAEs (comprising clinically significant findings on vital signs, physical examination, ECG, and laboratory parameters including change from baseline).
Measured: from baseline up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start26 Aug 2025
- Primary completion1 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-on-Chronic Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110441
- Sponsor's protocol ID
- G1090N_P1_25_1
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07110441
- Acronym / sponsor ID
- G1090N_P1_25_1
- Conditions
- Acute-on-Chronic Liver Failure
- Keywords
- Acute-on-Chronic Liver Failure; ACLF; G1090N, Tizoxanide, Nitazoxanide, Pharmacokinetics, Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1090N 300 mg | Experimental | Drug: Single Dose G1090NSubjects will recieve a single dose of G1090N |
| G1090N 600 mg | Experimental | Drug: Single Dose G1090N, Drug: Multiple dosing of G1090NSubjects will recieve single and multiple doses of G1090N |
| G1090N 900 mg | Experimental | Drug: Single Dose G1090N, Drug: Multiple dosing of G1090NSubjects will recieve single and multiple doses of G1090N |
| G1090N 1200 mg | Experimental | Drug: Single Dose G1090N, Drug: Multiple dosing of G1090NSubjects will recieve single and multiple doses of G1090N |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Healthy subjects with absence of clinically relevant abnormalities as determined by the Investigator or medically qualified designee based on a detailed medical history and complete physical examination;
- 2. Clinical laboratory test results for liver and renal function within the normal reference range. For all other clinical laboratory parameters, results outside the normal reference range to be confirmed by the Investigator and the Sponsor as not clinically significant;
- 3. Male or female subjects ≥18 and ≤55 years of age with a minimum body weight of 50 kg and a body mass index of ≥18.0 to ≤30.0 kg/m2 at the time of signing the informed consent form (ICF);
- 4. Subjects willing and able to comprehend and sign informed consent and to comply with the requirements of this study.
Key exclusion criteria (30 listed)
- 1. Significant history or clinical manifestation of any metabolic (including thyroid), allergic, dermatological, hepatic (including Gilbert's syndrome), renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal, neurological, or psychiatric disorder;
- 2. Experienced an acute illness within 14 days of SCR;
- 3. Positive serologic test for hepatitis B surface antigen, or for hepatitis C virus antibody, or human immunodeficiency virus I and II at SCR; positive coronavirus disease 2019 test at Day -1 of Part 1 or Part 2;
- 4. Frequent headaches (more than twice a month) and/or migraines, recurrent nausea and/or vomiting, or diarrhea;
- 5. Smokers, defined as having used tobacco- or nicotine-containing products within 6 months prior to SCR;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Dose G1090NSubjects will receive single ascending doses of G1090N up to 1200mg. | Drug | G1090N 1200 mg, G1090N 300 mg, G1090N 600 mg, G1090N 900 mg |
| Multiple dosing of G1090NSubjects will receive multiple ascending doses of G1090N up to 1200mg twice daily for 7 consecutive days. | Drug | G1090N 1200 mg, G1090N 600 mg, G1090N 900 mg |
Primary outcome
Maximum Concentration (Cmax)
Time frame: Up to Day 9
To evaluate pharmacokinetics (PK) following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for tizoxanide (TZ) and tizoxanide glucuronide (TZG) concentrations including but not limited to Cmax.
Time to Cmax (tmax)
Time frame: Up to Day 9
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to tmax.
Area under the plasma concentration-time curve (AUC)
Time frame: Up to Day 9
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to AUC.
Terminal half-life (t1/2)
Time frame: Up to Day 9
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to t1/2.
Amount excreted (Ae)
Time frame: Up to Day 8
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to Ae.
Renal clearance (CLr)
Time frame: Up to Day 8
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to CLr.
Fraction of dose excreted (fe)
Time frame: Up to Day 8
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to fe.
1 secondary outcome
To evaluate safety and tolerability following single and multiple ascending dose administration of G1090N in healthy subjects
Time frame: from baseline up to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single Dose G1090N and Multiple dosing of G1090N in people with Acute-on-Chronic Liver Failure, run by Genfit at 1 site in United States.
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 4 inclusion and 30 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Maximum Concentration (Cmax) (time frame: Up to Day 9). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.