Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
ICON - Lenexa
Lenexa, Kansas, United States, 66219-9746
Actively Recruiting
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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