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

Karuna Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Xanomeline/Trospium Chloride; Drug: Lithium; Drug: Valproic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06729970

CN012-0035

Details and patient eligibility

About

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

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

Part A

Experimental group

Treatment:

Drug: Lithium

Drug: Xanomeline/Trospium Chloride

Part B

Experimental group

Treatment:

Drug: Valproic Acid

Drug: Xanomeline/Trospium Chloride

Part C

Experimental group

Treatment:

Drug: Lithium

Drug: Xanomeline/Trospium Chloride

Part D

Experimental group

Treatment:

Drug: Valproic Acid

Drug: Xanomeline/Trospium Chloride