NCT06126575

A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Elacestrant dihydrochloride	A single oral dose of 200 mg elacestrant (2 x 100 mg tablets).

Timeline

• Start date: 2023-03-13
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2023-11-13
• Last updated: 2024-11-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study