Trials / Completed
CompletedNCT06853171
Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
An Open-label, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KarXT | Specified dose on specified days |
| DRUG | KarX-EC | Specified dose on specified days |
Timeline
- Start date
- 2025-04-29
- Primary completion
- 2025-07-22
- Completion
- 2025-07-22
- First posted
- 2025-02-28
- Last updated
- 2025-08-06
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06853171. Inclusion in this directory is not an endorsement.