Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Recruiting Study icon

Recruiting

Trial ID CN012-0035  |   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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-65
    Age Range
  • 1
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

print Print
email Email

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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.
    1. BMI of 18.0 to 32.0 kg/m2, inclusive.

      Exclusion Criteria

      Exclusion Criteria Icon
      :
      • 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.
        1. Parts B and D only: History of pancreatitis.
          1. Any significant acute or chronic medical illness, in the opinion of the investigator.
            1. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
              1. Parts E & F only: history of skin rash and mucus ulcerations of no obvious cause and Gilbert's syndrome
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A

                  ASSIGNED INTERVENTION
                  • Drug: Xanomeline/Trospium Chloride, Lithium

                  Study Arms

                  Experimental: Part B

                  ASSIGNED INTERVENTION
                  • Drug: Xanomeline/Trospium Chloride, Valproic Acid

                  Study Arms

                  Experimental: Part C

                  ASSIGNED INTERVENTION
                  • Drug: Xanomeline/Trospium Chloride, Lithium

                  Study Arms

                  Experimental: Part D

                  ASSIGNED INTERVENTION
                  • Drug: Xanomeline/Trospium Chloride, Valproic Acid

                  Study Arms

                  Experimental: Part E

                  ASSIGNED INTERVENTION
                  • Drug: Lamotrigine, Xanomeline/Trospium Chloride

                  Study Arms

                  Experimental: Part F

                  ASSIGNED INTERVENTION
                  • Drug: Lamotrigine, Xanomeline/Trospium Chloride
                  Take the first step to see if you Match to a Clinical Trial – Check Your Eligibility
                  Check Your Eligibility
                  Answer some questions about Your health to see if you may match to this trial
                  Match to a Trial
                  If you are a match, click on the study to see the list of study site locations
                  Select a Study Site Location
                  Select a study site location that is convenient for you
                  Register
                  Provide your contact details for the study site to connect with you.

                  Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you