Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT07118215

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

Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Updated on 2026-03-02

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be healthy males or females with no significant medical issues based on medical history, physical exam, ECG, vital signs, and lab tests
  • Body mass index (BMI) must be between 18.0 and 32.0 kg/m2
Not Eligible

You will not qualify if you...

  • Participants with organ dysfunction or abnormal physical exam, vital signs, ECG, or lab tests outside normal ranges
  • Those with liver diseases including cirrhosis, biliary duct problems, liver cancer, or active liver viral infections
  • Any significant acute or chronic illness determined by the investigator
  • History or high risk of urinary retention, gastric retention, narrow-angle glaucoma, prostate hypertrophy, or nocturia
  • Current or recent gastrointestinal diseases affecting drug absorption or metabolism
  • History of major surgeries impacting drug absorption, excluding uncomplicated appendectomy or hernia repair
  • History of active gastrointestinal obstruction
  • History of bladder stones
  • History of recurrent urinary tract infections
  • Other protocol-defined inclusion or exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

ICON - Lenexa

Lenexa, Kansas, United States, 66219-9746

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

First line of the email MUST contain NCT # and Site #.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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