Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390410
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
A Pharmacokinetic Study of Simufilam in Subjects with Impaired Hepatic Function
Sponsor:
Cassava Sciences Inc
Organization:
Cassava Sciences Inc
Study Overview
Official Title:
A Pharmacokinetic Study of Simufilam in Subjects with Impaired Hepatic Function
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None