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 CN012-0013  |   NCT07118215

A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin

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 KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.

print Print
email Email

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
    1. Participants must have BMI of 18.0 to 32.0 kg/m2.

      Exclusion Criteria

      Exclusion Criteria Icon
      :
      • Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
        1. Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.
          1. Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.
            1. Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
              1. Participants must not have current or recent (within 3 months of first study intervention administration) GI disease that could possibly affect drug ADME (eg, bariatric procedure).
                1. Participants must not have any major surgery, including GI surgery (eg, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
                  1. Participants must not have history of active GI obstructive disorder.
                    1. Participants must not have history of bladder stones.
                      1. Participants must not have history of recurrent urinary tract infections.
                        1. Other protocol define inclusion/exclusion criteria apply.
                          Additional Information *

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Part 1

                          ASSIGNED INTERVENTION
                          • Drug: KarXT, Midazolam

                          Study Arms

                          Experimental: Part 2

                          ASSIGNED INTERVENTION
                          • Drug: KarXT, Fexofenadine

                          Study Arms

                          Experimental: Part 3

                          ASSIGNED INTERVENTION
                          • Drug: KarXT, Digoxin
                          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

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