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Single Dose G1090N · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| G1090N 300 mg | EXPERIMENTAL | Subjects will recieve a single dose of G1090N |
| G1090N 600 mg | EXPERIMENTAL | Subjects will recieve single and multiple doses of G1090N |
| G1090N 900 mg | EXPERIMENTAL | Subjects will recieve single and multiple doses of G1090N |
| G1090N 1200 mg | EXPERIMENTAL | Subjects will recieve single and multiple doses of G1090N |
| Name | Type | Description |
|---|---|---|
| Single Dose G1090N | DRUG | Subjects will receive single ascending doses of G1090N up to 1200mg. |
| Multiple dosing of G1090N | DRUG | Subjects will receive multiple ascending doses of G1090N up to 1200mg twice daily for 7 consecutive days. |
Inclusion Criteria: * 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 w...
Single Dose G1090N is an investigational small molecule being developed for Acute-on-Chronic Liver Failure, a serious condition in patients with chronic liver disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Single Dose G1090N is being developed by Genfit SA, a biopharmaceutical company traded under the ticker GNFT. The company is conducting clinical research on this investigational drug for Acute-on-Chronic Liver Failure.
Single Dose G1090N is in Phase 1 clinical development. It remains investigational and has not received regulatory approval. A Phase 1 pharmacokinetic study has been completed, and the drug is still in the early stages of clinical testing.
Single Dose G1090N has one completed clinical trial, NCT07110441, a Phase 1 pharmacokinetic study of G1090N capsules in healthy volunteers. The study enrolled 52 participants in the United States and was a controlled, non-randomized, open-label trial.
Single Dose G1090N is also known as G1090N, which is nitazoxanide. The completed Phase 1 trial was titled 'Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers,' confirming that G1090N refers to the drug nitazoxanide.