Loading clinical trials...

A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function

NCT06390410•Cassava Sciences, Inc.

Summary

Evaluate simufilam levels in the blood of hepatically impaired individuals compared to Healthy individuals of similar demographics

Detailed Description

This is a Phase I, open label, single-dose study of simufilam 100 mg. Up to 34 subjects may be enrolled; 10 subjects with moderate hepatic impairment, 10 healthy volunteers with normal hepatic function (with the potential of 4 more), and if needed 10 subjects with mild hepatic impairment. Both males and females will be enrolled. The study will be conducted in 2 groups (with the potential of a third) assigned based on degree of hepatic impairment as follows: up to 10 subjects with moderate hepatic impairment (Child-Pugh score of 7-9) up to 10 health volunteers (matched to each hepatic impairment severity group) If needed up to 10 subjects with mild hepatic impairment (Child-Pugh score of 5-6), and an additional 4 healthy volunteers if needed to match the mild group

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The subject is willing and able to speak, read, and understand English and is willing to provide written informed consent.
•Male or female subjects between 18 and 75 years of age, inclusive.
•The subject has a body mass index (BMI) within 18-40 kg/m2.
•The subject must have renal function that is normal or consistent with mild renal insufficiency.
•The subject has normal/acceptable mental status for study participation in the opinion of the Investigator.
•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
•The subject must agree to comply with the drawing of blood samples for the pharmacokinetics (PK) assessments.
•The subject is willing and able to comply with all testing and requirements defined in the protocol.
•The subject is willing and able to remain at the study site unit for the duration of the study.
•The subject must be negative for the COVID virus at both the Screening Visit and the Check-In Visit.
+6 more criteria

Exclusion Criteria

•The subject has a clinically significant electrocardiogram (ECG) abnormality including, but not necessarily limited to, a confirmed QT interval by the Fridericia correction formula (QTcF) \> 470 msec (females) or \> 450 msec (males) based on WHO 2016 guidelines.
•The subject has had a clinically significant illness within 30 days prior to the Screening Visit.
•The subject has a medically significant comorbid illness that would impact the successful conduct of the study or achieving its objectives in the opinion of the Investigator and/or Medical Monitor.
•The subject has used a known strong CYP2C19 inhibitor (fluconazole, fluoxetine, fluvoxamine or ticlopidine) or inducer (rifampin) within 28 days prior to admission, or 5 half-lives (whichever is longer).
•The subject has consumed alcohol, grapefruit, grapefruit juice, caffeine- or xanthine-containing products within 72 hours before dosing or intends to use any of these products during the study.
•The subject has smoked more than 10 cigarettes per day on average for the past 6 months.
•The subject has a history of substance abuse within 12 months of the Screening Visit.
•The subject tests positive on the urine drug screen for drugs of abuse at either the Screening Visit or the Check-In Visit (Note - Subjects with hepatic impairment who are prescribed medications assessed in the urine drug screen \[e.g, opiates, benzodiazepines\] need not be excluded based on a positive urine drug screen).
•The subject has a positive ethanol breath test at either the Screening Visit or the Check-In Visit.
•The subject has a history of regular alcohol consumption defined as greater than 7 drinks per week for women and 14 drinks per week for men within six months prior to the Screening Visit.
+20 more criteria

Locations (3)

Orange County Research Center

Lake Forest, California, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Key Dates

Start Date

June 26, 2024

Primary Completion Date

December 7, 2024

Completion Date

December 7, 2024

Last Updated

January 7, 2025

Enrollment

ACTUAL participants

Conditions

Hepatic Insufficiency

Interventions

Simufilam

DRUG

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037

Hepatic InsufficiencyCirrhosis, Liver

View study

TERMINATEDPHASE1

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

NCT05209295

Hepatic InsufficiencyNeoplasms

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function

Inclusion Criteria

Exclusion Criteria

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies

Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)