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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06729970

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

133

Starts

2024-12-26

Expected to finish

2026-01-23

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female [individual not of childbearing potential (INOCBP)] participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory determinations.
• BMI of 18.0 to 32.0 kg/m2, inclusive.

You may not qualify if…

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Note: Any grade of hepatic impairment (Child-Pugh Grade A or higher) is excluded.
• Parts B and D only: History of pancreatitis.
• Any significant acute or chronic medical illness, in the opinion of the investigator.
• History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
• Parts E \& F only: history of skin rash and mucus ulcerations of no obvious cause and Gilbert's syndrome
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0001 — Los Alamitos, California, United States

Full record on ClinicalTrials.gov

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