A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin
NCT ID: NCT07118215
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-09-29
2026-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1
KarXT
Specified dose on specified days
Midazolam
Specified dose on specified days
Part 2
KarXT
Specified dose on specified days
Fexofenadine
Specified dose on specified days
Part 3
KarXT
Specified dose on specified days
Digoxin
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
Midazolam
Specified dose on specified days
Fexofenadine
Specified dose on specified days
Digoxin
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have BMI of 18.0 to 32.0 kg/m2.
Exclusion Criteria
* Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.
* Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.
* 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.
* 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).
* 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).
* Participants must not have history of active GI obstructive disorder.
* Participants must not have history of bladder stones.
* Participants must not have history of recurrent urinary tract infections.
18 Years
65 Years
ALL
Yes
Sponsors
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Karuna Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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ICON - Lenexa
Lenexa, Kansas, United States
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Patrick Yao, Site 0001
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0013
Identifier Type: -
Identifier Source: org_study_id
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