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
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
236
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-06-27
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Number of sites
1
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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.
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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
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-03-29
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First posted
2025-07-14
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Registry last updated
2026-08-17
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Primary completion date
2027-03-29
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Start date
2025-06-27
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Participants
236
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Participant count basis
Estimated
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Planned participants
236
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Protocol amendments
2
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07063342
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ClinicalTrials.gov ID
NCT07063342
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

  • BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
clinicaltrials.gov

  • Quotient SciencesNottingham, United KingdomRecruiting
Sources for sites
clinicaltrials.gov

  • U1111-1321-3511
  • IRAS1011809
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (4)