Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NTZ
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 an investigational small molecule being studied for use in patients with renal impairment and moderate hepatic impairment. It is in Phase 1 clinical development for these conditions, which fall under the gastrointestinal therapeutic area.
Nitazoxanide is being developed by Genfit SA Sponsored ADR, a biopharmaceutical company. The company's stock is traded under the ticker symbol GNFT.
Nitazoxanide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Its clinical trials are focused on evaluating its pharmacokinetics in patients with renal or hepatic impairment.
Nitazoxanide has completed two Phase 1 clinical trials. The first, NCT05116826, studied its pharmacokinetics in patients with moderate or severe hepatic impairment. The second, NCT05368935, studied its pharmacokinetics in subjects with renal impairment. Both trials were conducted in the United States.
Nitazoxanide is the drug name used in clinical trials. No alternative names have been associated with this drug in the context of its development for renal and hepatic impairment.