Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nitazoxanide · 2 trials · 6 indications
Plasma pharmacokinetic (PK) parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
In participants with moderate and severe hepatic impairment compared to healthy volunteers
In participants with moderate and severe hepatic impairment compared to healthy volunteers
In participants with moderate and severe hepatic impairment compared to healthy volunteers
| Arm | Type | Description |
|---|---|---|
| Healthy Control Match (RF ≥ 90 mL/min) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Mild Renal Impairment (RF ≥ 60 to < 90 mL/min) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Severe Renal Impairment (RF < 30 mL/min and not on dialysis) | EXPERIMENTAL | 500 mg Twice Daily for 7 days |
| Healthy Control Match (Normal hepatic function) | EXPERIMENTAL | NTZ 500 mg twice a day for 7 days |
| Moderate Child-Pugh B (Moderate hepatic impairment) | EXPERIMENTAL | NTZ 500 mg twice a day for 7 days |
| Severe Child-Pugh C (Severe hepatic impairment) | EXPERIMENTAL | NTZ 500 mg twice a day for 7 days |
| Name | Type | Description |
|---|---|---|
| Nitazoxanide | DRUG | 500 mg Twice Daily for 7 days |
Inclusion Criteria: 1. Males or females, between 18 and 80 years of age, inclusive 2. With a minimum body weight of ≥ 50.0 kg for males and ≥ 45.0 kg for females and within a BMI range of 18.0 to 40.0 kg/m\^2, inclusive 3. Females participating in this study must be of non-childbearing potential or...
Nitazoxanide is being studied for use in patients with Renal Impairment and Moderate Hepatic Impairment. It is a small molecule being developed by Genfit SA for gastrointestinal conditions. The drug is currently in Phase 1 clinical development, with studies focused on understanding its pharmacokinetic parameters in these patient populations.
Nitazoxanide is a small molecule therapeutic being developed for gastrointestinal conditions. The specific molecular target of Nitazoxanide is not disclosed in the available information. The ongoing Phase 1 studies are designed to evaluate its pharmacokinetic parameters in patients with renal and hepatic impairment.
Nitazoxanide is being developed by Genfit SA, which trades under the ticker GNFT. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics in patients with renal impairment and moderate hepatic impairment. Genfit is focused on developing this small molecule for gastrointestinal therapeutic applications.
Nitazoxanide is in Phase 1 clinical development. It is an investigational drug being studied for use in patients with renal impairment and moderate hepatic impairment. The drug has completed one Phase 1 trial with 77 participants, and it is not yet approved by regulatory authorities.
Nitazoxanide has been studied in two completed Phase 1 clinical trials. NCT05116826 evaluated pharmacokinetic parameters in patients with moderate and severe hepatic impairment, enrolling 25 participants. NCT05368935 assessed pharmacokinetics in subjects with renal impairment, enrolling 77 participants. Both trials were conducted in the United States.
Nitazoxanide is the primary name for this drug candidate being developed by Genfit SA. No alternative names for Nitazoxanide have been identified in the available information. The drug is being studied under its current name in clinical trials for renal and hepatic impairment indications.