NCT06390410

A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Cassava Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	Simufilam	100 mg PTI-125

Timeline

• Start date: 2024-06-26
• Primary completion: 2024-12-07
• Completion: 2024-12-07
• First posted: 2024-04-30
• Last updated: 2025-01-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study