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NCT06853171 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders

A Phase 1 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT06853171: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT06853171 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06853171, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in adolescents with psychiatric disorders.

Interventions

  • DRUG KarXT
  • DRUG KarX-EC

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2025-04-29
Est. Completion 2025-07-22
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT06853171 record still lists

NCT06853171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 2 interventions - of which KarXT is the first listed.

NCT06853171 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06853171 about?

NCT06853171 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders". This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in adolescents with psychiatric disorders.

What is the current status of trial NCT06853171?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-04-29. Estimated completion is 2025-07-22.

What interventions are being tested in trial NCT06853171?

The interventions under investigation include: KarXT (DRUG), KarX-EC (DRUG).

Who is sponsoring clinical trial NCT06853171?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06853171's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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 NCT06853171, the US trial registry maintained by the National Library of Medicine. NCT06853171 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.