KarXT's effects on midazolam, fexofenadine, and digoxin blood levels in healthy adults
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
This will test whether taking KarXT changes the blood levels of midazolam, fexofenadine, and digoxin in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Karuna Therapeutics, Inc., a Bristol Myers Squibb company Industry-sponsored |
| Locations | 1 site (Lenexa, Kansas) |
| Trial ID | NCT07118215 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 interventional pharmacokinetic study in healthy adult volunteers to see if KarXT alters plasma concentrations of the probe drugs midazolam, fexofenadine, and digoxin. Participants will receive KarXT and the probe drugs with timed blood sampling to measure drug concentrations over a defined period. The study will compare standard PK parameters (for example, Cmax and AUC) with and without KarXT to identify any changes suggesting metabolic or transporter interactions. Safety and tolerability will be monitored throughout by vital signs, ECGs, physical exams, and clinical laboratory tests.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with BMI 18.0–32.0 kg/m2 who have no clinically significant medical conditions and meet normal laboratory, ECG, and physical exam criteria.
Not a fit: People with active medical illness, organ dysfunction (including significant liver disease), high risk of urinary retention or narrow-angle glaucoma, or those taking the listed probe drugs for medical reasons are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could guide safe co-prescribing and dosing recommendations when KarXT is used with drugs metabolized or transported by the same pathways.
How similar studies have performed: Drug–drug interaction studies using probe substrates are a standard, successful method for characterizing PK interactions for many central nervous system agents, though KarXT-specific interaction data are comparatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lenexa, Kansas
- ICON - Lenexa — Lenexa, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.