Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers

NCT07110441 | Completed Phase 1 FDA Drug

• 1 other identifier: G1090N_P1_25_1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

Conditions

Acute-on-Chronic Liver Failure

Keywords

Acute-on-Chronic Liver Failure; ACLF; G1090N, Tizoxanide, Nitazoxanide, Pharmacokinetics, Healthy volunteer

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to Day 8

Secondary Outcomes (1)

• To evaluate safety and tolerability following single and multiple ascending dose administration of G1090N in healthy subjects

  from baseline up to Day 14

Study Arms (4)

G1090N 300 mg

EXPERIMENTAL

Subjects will recieve a single dose of G1090N

Drug: Single Dose G1090N

G1090N 600 mg

EXPERIMENTAL

Subjects will recieve single and multiple doses of G1090N

Drug: Single Dose G1090N; Drug: Multiple dosing of G1090N

G1090N 900 mg

EXPERIMENTAL

Subjects will recieve single and multiple doses of G1090N

Drug: Single Dose G1090N; Drug: Multiple dosing of G1090N

G1090N 1200 mg

EXPERIMENTAL

Subjects will recieve single and multiple doses of G1090N

Drug: Single Dose G1090N; Drug: Multiple dosing of G1090N

Interventions

Single Dose G1090N DRUG

Subjects will receive single ascending doses of G1090N up to 1200mg.

G1090N 1200 mg; G1090N 300 mg; G1090N 600 mg; G1090N 900 mg

Multiple dosing of G1090N DRUG

Subjects will receive multiple ascending doses of G1090N up to 1200mg twice daily for 7 consecutive days.

G1090N 1200 mg; G1090N 600 mg; G1090N 900 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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;
• \. 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;
• \. 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);
• \. Subjects willing and able to comprehend and sign informed consent and to comply with the requirements of this study.

You may not qualify if:

• \. 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;
• \. Experienced an acute illness within 14 days of SCR;
• \. 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;
• \. Frequent headaches (more than twice a month) and/or migraines, recurrent nausea and/or vomiting, or diarrhea;
• \. Smokers, defined as having used tobacco- or nicotine-containing products within 6 months prior to SCR;
• \. 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:
• 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;
• \. 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;
• \. 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.
• \. 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;

Sponsors & Collaborators

• Genfit: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 7, 2025
• Study Start: August 26, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 3, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-09

Locations

US (1)