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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06853171
Phase
PHASE1
Status
Completed

Conditions

  • Psychiatric Disorders

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • KarXT — DRUG
    Specified dose on specified days
  • KarX-EC — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Apr 29, 2025
Status verified
Jul 2025
Primary completion
Jul 22, 2025
Completion
Jul 22, 2025

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2
  • Experimental: Cohort 3

Primary Outcome Measure

Number of participants with Adverse Events (AEs) [ Time Frame: Up to Day 43 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Local Institution - 0005Little RockArkansas72204-
Local Institution - 0006OrangeCalifornia92868-
Local Institution - 0007DecaturGeorgia30030-
Local Institution - 0008Overland ParkKansas66212-

Find similar trials in Little Rock, AR

By research site
Local Institution - 0005· Little Rock, ARLocal Institution - 0006· Orange, CALocal Institution - 0007· Decatur, GALocal Institution - 0008· Overland Park, KS

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