Compare new KarX and KarT pill versions with KarXT and KarX-EC and check food effects in healthy adults
Official title: Phase 1, 4-Part, Open-label (Parts 1 to 3) and Double-blind (Part 4) Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants, and to Evaluate Alternative Formulations of KarX (BMS-986519) and KarXT (BMS-986510) Following Single and Multiple Ascending Doses in Healthy Adult Participants
Run by Bristol-Myers Squibb · NCT07063342 · Data updated 2026-11-12
This test will compare new KarX and KarT medication prototypes against the existing KarXT and KarX-EC formulations and see how eating affects selected prototypes when taken multiple times by healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 236 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Status | Recruiting |
| Started | June 27, 2025 |
| Main results expected | March 29, 2027 |
| Study ends | March 29, 2027 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07063342 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults with BMI between 18.0 and 32.0 kg/m2 who meet other protocol criteria are the intended participants.
✕Probably not a fit
People with active medical conditions, those who are pregnant or breastfeeding, or individuals outside the required BMI and protocol criteria are unlikely to receive benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional study enrolls healthy adult volunteers to receive single doses of novel KarX and KarT prototypes alongside the KarXT and KarX-EC reference formulations to compare pharmacokinetics and tolerability. Selected prototypes will then be given repeatedly to explore the effect of food on absorption and safety. The protocol will include clinical assessments, blood sampling for drug levels, and monitoring for adverse events. Findings will inform which formulations move forward and help set dosing recommendations for later trials.
Why it matters
Potential benefit: If successful, the study could identify formulations with improved absorption or tolerability and provide dosing guidance that benefits future patients.
How similar studies have gone: Formulation comparison and food-effect studies are standard in drug development and have often succeeded in identifying optimized dosing and formulations, and KarXT has previously been studied clinically.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where it's running
-
Quotient Sciences
Nottingham, Nottinghamshire, United Kingdom Recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.