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OpenTrials
Completed

NCT Number: NCT07118215

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Lenexa, Kansas, 66219-9746, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Participants must have BMI of 18.0 to 32.0 kg/m2.

Exclusion criteria

  • 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.
  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Other names: BMS-986510, Xanomeline, Trospium Chloride

midazolam

Drug

Specified dose on specified days

fexofenadine

Drug

Specified dose on specified days

Digoxin

Drug

Specified dose on specified days

Primary outcomes

  1. Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT

    Time frame: Up to approximately day 24

  2. Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT

    Time frame: Up to approximately day 24

  3. Part 2: GMR of Cmax of fexofenadine with and without KarXT

    Time frame: Up to approximately day 24

  4. Part 2: GMR of AUC of fexofenadine with and without KarXT

    Time frame: Up to approximately day 24

  5. Part 3: GMR of Cmax of digoxin with and without KarXT

    Time frame: Up to approximately day 24

  6. Part 3: GMR of AUC of digoxin with and without KarXT

    Time frame: Up to approximately day 24

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately day 47

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately day 47

  3. Number of participants with physical examination abnormalities

    Time frame: Up to approximately day 24

  4. Number of participants with vital sign abnormalities

    Time frame: Up to approximately day 24

  5. Number of participants with 12-lead electrocardiogram abnormalities (ECGs)

    Time frame: Up to approximately day 24

  6. Number of participants with clinical laboratory assessment abnormalities

    Time frame: Up to approximately day 24

  7. Number of participants with suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to approximately day 24

  8. Number of participants with adverse event of special interest (AESIs)

    Time frame: Up to approximately day 47

Sponsors and collaborators

Lead sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Industry

Registry information

Official study title

A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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