Trial Profile

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: Recruiting

Phase of Trial: Phase I

Latest Information Update: 01 Oct 2025

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At a glance

Drugs Trospium chloride/xanomeline (Primary) ; Lamotrigine; Lithium; Valproic acid
Indications Psychotic disorders
Focus Pharmacokinetics
Sponsors Karuna Therapeutics

28 Aug 2025 Planned End Date changed from 17 Oct 2025 to 18 Jan 2026.
28 Aug 2025 Planned primary completion date changed from 17 Oct 2025 to 18 Jan 2026.
09 Jul 2025 Planned End Date changed from 14 Aug 2025 to 17 Oct 2025.

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