NCT06729970

A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Xanomeline/Trospium Chloride	Specified dose on specified days
DRUG	Lithium	Specified dose on specified days
DRUG	Valproic Acid	Specified dose on specified days
DRUG	Lamotrigine	Specified dose on specified days

Timeline

• Start date: 2024-12-26
• Primary completion: 2026-01-23
• Completion: 2026-01-23
• First posted: 2024-12-12
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study