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: 09 Jul 2025

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

09 Jul 2025 Planned End Date changed from 14 Aug 2025 to 17 Oct 2025.
01 Jul 2025 Given protocol has been amended as above-1) Number of treatment arms has been changed from 4 to 6. 2) Planned number of patients has been changed from 88 to 130. 3) Time frame of primary endpoints has been changed Up to day 47.
01 Jul 2025 Planned number of patients changed from 88 to 130.

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com