Status and phase
Conditions
Treatments
About
Evaluate simufilam levels in the blood of hepatically impaired individuals compared to Healthy individuals of similar demographics
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Additional inclusion criteria specific for subjects with normal hepatic function:
Additional inclusion criteria specific for subjects with hepatic impairment:
Subjects with hepatic impairment with other stable, chronic medical conditions (e.g., hypertension, hyperlipidemia, diabetes) may be included if, in the opinion of the Investigator and Medical Monitor, the abnormality will not significantly alter the disposition of the drug and will not interfere with interpretation of the data.
The subject with moderate or mild hepatic impairment has been diagnosed at least 6 months prior to Screening.
The subject with hepatic impairment has clinical laboratory tests that are considered clinically stable and consistent with the subject's disease, in the opinion of the investigator.
Exclusion criteria
Additional exclusion criteria specific for subjects with normal hepatic function:
The subject with normal hepatic function has or has had hepatitis C, as confirmed by a positive hepatitis C virus (HCV) antibody test at the Screening Visit.
The subject with normal hepatic function has used prescription or over the counter (OTC) medication within 7 days prior to the Check-In visit, or intends to use any prescription or OTC medication during the study, with the following exceptions:
Additional exclusion criteria specific for subjects with hepatic impairment:
Primary purpose
Allocation
Interventional model
Masking
27 participants in 3 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal