NCT07118215 A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin
| NCT ID | NCT07118215 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Karuna Therapeutics, Inc., a Bristol Myers Squibb company |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2026-06-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-09-29 with a primary completion date of 2026-06-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07118215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07118215 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07118215 currently recruiting?
Yes, NCT07118215 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07118215 trial being conducted?
This trial is being conducted at Lenexa, United States.
Who is sponsoring the NCT07118215 clinical trial?
NCT07118215 is sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 60 participants.