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

NCT06126575 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Elacestrant dihydrochloride

A single oral dose of 200 mg elacestrant (2 x 100 mg tablets).

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2024-11-11
Completion
2024-11-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126575 on ClinicalTrials.gov