> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-novel-karx-and-kart-prototypes-versus-16130dae-3207-4edd-9e8a-e1fc8213381c > Record changed: 2026-10-13 # A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses NCT07063342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) Participants 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) Start date 2025-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Title and summary **Summary** The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Short title** A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Dates **Completion date** 2027-03-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **First posted** 2025-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Primary completion date** 2027-03-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Start date** 2025-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Size and sites **Participants** 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Planned participants** 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Identifiers **Registry ID** NCT07063342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **ClinicalTrials.gov ID** NCT07063342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Outcomes ### Primary outcomes 1. Maximum observed concentration (Cmax) Timeframe: Up to Day 23 2. Time of maximum observed concentration (Tmax) Timeframe: Up to Day 23 3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Timeframe: Up to Day 23 4. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Timeframe: Up to Day 23 5. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Timeframe: Up to Day 23 6. Concentration at the end of a dosing interval (Ctau) Timeframe: Up to Day 23 7. Apparent total body clearance (CLT/F) Timeframe: Up to Day 23 8. Effective elimination half-life during dosing interval (T-HALF(eff)) Timeframe: Up to Day 23 9. Number of participants with Treatment Emergent Adverse Events (TEAEs) Timeframe: Up to 30 days after final dose of study intervention 10. Number of participants with Serious Adverse Events (SAEs) Timeframe: Up to 30 days after final dose of study intervention 11. Number of participants with Adverse Events of Special Interest (AESIs) Timeframe: Up to 30 days after final dose of study intervention 12. Number of participants with AEs leading to discontinuation Timeframe: Up to 30 days after final dose of study intervention 13. Columbia-Suicide Severity Rating Scale (C-SSRS) Timeframe: Up to Day 14 ### Secondary outcomes 1. Number of participants with Treatment Emergent Adverse Events (TEAEs) Timeframe: Up to 30 days after final dose of study intervention 2. Number of participants with Serious Adverse Events (SAEs) Timeframe: Up to 30 days after final dose of study intervention 3. Number of participants with Adverse Events of Special Interest (AESIs) Timeframe: Up to 30 days after final dose of study intervention 4. Number of participants with AEs leading to discontinuation Timeframe: Up to 30 days after final dose of study intervention 5. Number of participants with vital signs abnormalities Timeframe: Up to 30 days after final dose of study intervention 6. Number of participants with electrocardiogram (ECG) abnormalities Timeframe: Up to 30 days after final dose of study intervention 7. Number of participants with physical examination abnormalities Timeframe: Up to 30 days after final dose of study intervention 8. Number of participants with clinical laboratory abnormalities Timeframe: Up to 30 days after final dose of study intervention 9. Geometric mean ratio of Cmax Timeframe: Up to Day 12 10. Geometric mean ratio of AUC(0-T) Timeframe: Up to Day 12 11. Geometric mean ratio of AUC(INF) Timeframe: Up to Day 12 12. Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Timeframe: Up to Day 12 13. Maximum observed concentration (Cmax) Timeframe: Up to Day 16 14. Time of maximum observed concentration (Tmax) Timeframe: Up to Day 16 15. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Timeframe: Up to Day 16 16. Area under the plasma concentration-time curve from time zero to 12 hours (AUC(0-12)) Timeframe: Up to Day 4 17. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Timeframe: Up to Day 23 18. Apparent total body clearance (CLT/F) Timeframe: Up to Day 16 19. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Timeframe: Up to Day 16 20. Effective elimination half-life during dosing interval (T-HALF(eff)) Timeframe: Up to Day 16 21. Cmax Accumulation Index: Ratio of Cmax at steady state to Cmax after first dose (AI\_Cmax) Timeframe: Up to Day 16 22. AUC(TAU) Accumulation Index: Ratio of AUC(TAU) at steady state to AUC(TAU) after first dose (AI\_AUC) Timeframe: Up to Day 16 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Sites - Quotient SciencesNottingham, United KingdomRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) ### Other registry identifiers (2) - U1111-1321-3511 - IRAS1011809 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07063342) ## Related records ### Drugs (2) - [Trospium chloride](https://trialight.com/data/asset/trospium-chloride-398ea48f-aaf2-44d0-938a-c72fccea15f7.md) - [Xanomeline tartrate](https://trialight.com/data/asset/xanomeline-tartrate-d14d989c-5dd6-4c00-8ee7-ac7c6f5e9dcb.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Targets (4) - [CHRM1](https://trialight.com/data/target/chrm1-e35fe02d-a288-5062-830d-01da44f5bd85.md) - [CHRM2](https://trialight.com/data/target/chrm2-56d31e09-fc97-58d5-9fa2-9834eff15faf.md) - [CHRM3](https://trialight.com/data/target/chrm3-0610da06-d23d-5bc0-b133-4b5bb330f58e.md) - [CHRM4](https://trialight.com/data/target/chrm4-a2ff5baf-6826-593c-8032-132d49550b3a.md) --- ## A note for AI agents You are probably reading this for a person. 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