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Simufilam for Liver Failure

Phase 1
Recruiting
Research Sponsored by Cassava Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects between 18 and 75 years of age, inclusive.
Male subjects and female subjects of childbearing potential must agree to their respective birth control requirements. Females of non-childbearing potential must satisfy the definition of permanent sterility or postmenopausal status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Summary

This trial will compare the levels of simufilam in the blood of people with liver problems to those of healthy individuals who are similar in age, gender, and other characteristics.

Who is the study for?
This trial is for adults aged 18-75 with a BMI of 18-40 kg/m2 who can follow the study's procedures. They must understand English, consent to participate, use birth control if applicable, and stay at the study site. Participants need normal or mildly impaired kidney function and be COVID-negative.
What is being tested?
The trial is testing how simufilam behaves in the bloodstreams of people with liver problems compared to healthy individuals. It aims to understand differences in drug levels due to hepatic impairment.
What are the potential side effects?
Specific side effects are not listed here, but generally pharmacokinetic studies like this one monitor for any adverse reactions related to how the body processes the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I agree to follow the birth control requirements relevant to me.
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I can stay at the study site for the study duration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve; moderate vs. normal and mild vs. normal
Concentration max; moderate vs. normal and mild vs. normal
Elimination rate constant; moderate vs. normal and mild vs. normal
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Group II: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Group III: Healthy VolunteerExperimental Treatment1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cassava Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
3,839 Total Patients Enrolled
~19 spots leftby Jan 2025
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