Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126575
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-11-06
Brief Title:
A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function
Sponsor:
Stemline Therapeutics Inc
Organization:
Stemline Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-Label Non-randomized Parallel-Group Study to Evaluate the Pharmacokinetics Safety and Tolerability of a Single Oral Dose of 200 mg Elacestrant in Subjects With Normal Hepatic Function or Severe Hepatic Impairment
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a Phase 1 multi-center open-label non-randomized parallel group study to evaluate the effect of severe hepatic impairment on the PK safety and tolerability of a single oral dose of Elacestrant
Detailed Description:
A total of 16 subjects will be recruited and divided between the following two Groups
Group 1 8 subjects with severe hepatic impairment Group 2 8 subjects with normal hepatic function control group
On Day 1 subjects will receive a single oral dose of 200 mg Elacestrant 2 x 100 mg tablets Safety assessment and blood sampling for Elacestrant analysis on plasma will be performed at predefined time points up to 240 hours post
The total duration of study participation for each subject from screening to the follow up call is anticipated to be approximately 6 weeks
Group 1 8 subjects with severe hepatic impairment Group 2 8 subjects with normal hepatic function control group
On Day 1 subjects will receive a single oral dose of 200 mg Elacestrant 2 x 100 mg tablets Safety assessment and blood sampling for Elacestrant analysis on plasma will be performed at predefined time points up to 240 hours post
The total duration of study participation for each subject from screening to the follow up call is anticipated to be approximately 6 weeks
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