Trials / Recruiting
RecruitingNCT07257120
KarXT Concentrations in the Breast Milk and Plasma of Lactating Females
A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to characterize the PK of xanomeline and trospium in breast milk and plasma in healthy lactating female participants, following multiple oral administration of KarXT in healthy lactating participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xanomeline/trospium chloride | Specified dose on specified days |
Timeline
- Start date
- 2026-01-09
- Primary completion
- 2027-11-30
- Completion
- 2027-11-30
- First posted
- 2025-12-02
- Last updated
- 2026-02-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07257120. Inclusion in this directory is not an endorsement.