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NCT06126575 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Stemline Therapeutics.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT06126575: Completed Phase 1 study, sponsored by Stemline Therapeutics.

NCT06126575 is a Phase 1 study that has completed, run by Stemline Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06126575, a Phase 1 study, has completed, sponsored by Stemline Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

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.

Interventions

  • DRUG Elacestrant dihydrochloride

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2023-03-13
Est. Completion 2024-11-11
Phase Phase 1
Stemline Therapeutics

17 total trials

What the finished NCT06126575 record still lists

NCT06126575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which Elacestrant dihydrochloride is the first listed.

NCT06126575 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06126575 about?

NCT06126575 is a clinical study titled "A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function". 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.

What is the current status of trial NCT06126575?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-03-13. Estimated completion is 2024-11-11.

What interventions are being tested in trial NCT06126575?

The interventions under investigation include: Elacestrant dihydrochloride (DRUG).

Who is sponsoring clinical trial NCT06126575?

This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06126575's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06126575, the US trial registry maintained by the National Library of Medicine. NCT06126575 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.