G1090N for Liver Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study how the body processes the medication G1090N (Nitazoxanide) and to assess its safety in healthy individuals. Researchers will administer different doses to participants to observe absorption and tolerance. The trial seeks individuals who are generally healthy, with normal liver and kidney function, and without significant medical issues affecting daily life. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription or nonprescription drugs, including vitamins and supplements, at least 30 days before the trial, unless the study doctor and sponsor say it's okay.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that nitazoxanide, the main ingredient in G1090N, is generally safe at approved doses. In past studies, over 2,000 people took nitazoxanide without serious issues. Most participants tolerated it well, though some experienced mild side effects like stomach upset, which are common with many medications.
Nitazoxanide is already FDA-approved for other uses, indicating it is generally safe when used correctly. However, more research is needed to understand its effects on the liver and heart at higher doses or with long-term use.
Overall, the safety data for G1090N appears promising. Since this is a Phase 1 trial, the main goal is to assess safety and tolerance. This helps ensure the treatment is safe for larger studies in the future.12345Why do researchers think this study treatment might be promising?
Researchers are excited about G1090N (Nitazoxanide) because it offers a unique approach to treating infections by targeting viral replication, which is different from the standard antiviral treatments that often focus on symptoms or immune modulation. Unlike other antivirals that can take longer to act, Nitazoxanide has the potential to show results more quickly due to its mechanism of interfering directly with viral protein synthesis. Additionally, G1090N is being tested in various dosages, from 300 mg to 1200 mg, which could provide flexibility in tailoring treatment according to the severity of the condition. This flexibility and its distinct mechanism make Nitazoxanide a promising candidate in the antiviral treatment space.
What evidence suggests that G1090N could be effective?
Research has shown that nitazoxanide can help the body eliminate viruses more quickly. In one study, only 0.5% of people taking nitazoxanide became very sick, compared to 3.6% of those who did not take it. Another study found that it cleared viruses more rapidly than usual treatments. For conditions like diarrhea and inflammation of the intestine, 96% of patients who took nitazoxanide improved, compared to just 41% of those who didn't take it. These studies suggest that nitazoxanide can be effective for certain infections. Participants in this trial will receive different dosages of G1090N (Nitazoxanide) to evaluate its effectiveness and safety.678910
Are You a Good Fit for This Trial?
Healthy individuals aged 18-55, with a body weight of at least 50 kg and BMI between 18.0 to ≤30.0 kg/m2, who have normal liver and kidney function tests can join this trial. They must understand the study requirements and consent to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single and multiple ascending doses of G1090N to assess pharmacokinetics, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- G1090N (Nitazoxanide)
Trial Overview
The trial is testing how G1090N (Nitazoxanide) capsules are processed by the body when given in single or multiple doses to healthy volunteers. It's an early-stage study focusing on safety and how the drug moves through and out of the body.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Subjects will recieve single and multiple doses of G1090N
Subjects will recieve single and multiple doses of G1090N
Subjects will recieve a single dose of G1090N
Subjects will recieve single and multiple doses of G1090N
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genfit
Lead Sponsor
Citations
The Effect of Nitazoxanide on the Clinical Outcomes in ...
Nitazoxanide was effective in accelerating viral clearance compared with placebo (RR: 1.30 with 95% CI 1.08, 1.56, p = 0.006) and reducing oxygen requirements.
A randomized double-blind placebo-controlled clinical trial ...
1 of 184 (0·5%) treated with nitazoxanide progressed to severe illness compared to 7 of 195 (3·6%) treated with placebo (key secondary analysis, odds ratio 5·6 ...
Full article: Clinical outcomes, virological efficacy and ...
However, nitazoxanide was associated with a higher virological eradication rate than placebo or standard care (RD, 0.09; 95% CI: 0.01 to 0.17; P = 0.03).
Safety and Efficacy Study of Nitazoxanide in the Treatment ...
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...
Effect of Nitazoxanide in Diarrhea and Enteritis Caused by ...
Results: Twenty-seven (96%) of the 28 patients receiving nitazoxanide tablets responded clinically compared with 11 (41%) of 27 patients who received placebo (P ...
Safety Data Sheet
RTECS Number. 55981-09-4 Nitazoxanide VN7830000. · Information on toxicological effects. · Acute toxicity: · LD/LC50 values that are relevant ...
Nitazoxanide tablets - accessdata.fda.gov
The safety of nitazoxanide was evaluated in 2177 HIV-uninfected subjects who received nitazoxanide at the recommended dose for at least three days. In pooled ...
GENFIT Presents Promising New Preclinical Data on NTZ ...
We eagerly await the upcoming safety data from G1090N in healthy volunteers, along with potential efficacy signals on key biomarkers from ex- ...
Review of safety and minimum pricing of nitazoxanide for ...
Nitazoxanide demonstrates a good safety profile at approved doses. However, further evidence is required regarding hepatorenal and cardiovascular effects, as ...
Nitazoxanide (oral route) - Side effects & dosage
However, safety and efficacy of nitazoxanide oral suspension has not been established in children younger than 1 year of age.
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