Healthy Volunteers
Conditions
Brief 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.
Interventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
DRUGXanomeline MR
Specified dose on specified days
DRUGXanomeline
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to Day 23 |
| Time of maximum observed concentration (Tmax) | Up to Day 23 |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 23 |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 23 |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to Day 23 |
| Concentration at the end of a dosing interval (Ctau) | Up to Day 23 |
| Apparent total body clearance (CLT/F) | Up to Day 23 |
| Effective elimination half-life during dosing interval (T-HALF(eff)) | Up to Day 23 |
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to 30 days after final dose of study intervention |
| Number of participants with Serious Adverse Events (SAEs) | Up to 30 days after final dose of study intervention |
| Number of participants with Adverse Events of Special Interest (AESIs) | Up to 30 days after final dose of study intervention |
| Number of participants with AEs leading to discontinuation | Up to 30 days after final dose of study intervention |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to 30 days after final dose of study intervention |
| Number of participants with Serious Adverse Events (SAEs) | Up to 30 days after final dose of study intervention |
| Number of participants with Adverse Events of Special Interest (AESIs) | Up to 30 days after final dose of study intervention |
| Number of participants with AEs leading to discontinuation | Up to 30 days after final dose of study intervention |
| Number of participants with vital signs abnormalities | Up to 30 days after final dose of study intervention |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 30 days after final dose of study intervention |
| Number of participants with physical examination abnormalities | Up to 30 days after final dose of study intervention |
| Number of participants with clinical laboratory abnormalities | Up to 30 days after final dose of study intervention |
| Geometric mean ratio of Cmax | Up to Day 12 |
| Geometric mean ratio of AUC(0-T) | Up to Day 12 |
| Geometric mean ratio of AUC(INF) | Up to Day 12 |
| Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to Day 12 |
| Maximum observed concentration (Cmax) | Up to Day 16 |
| Time of maximum observed concentration (Tmax) | Up to Day 16 |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 16 |
| Area under the plasma concentration-time curve from time zero to 12 hours (AUC(0-12)) | Up to Day 4 |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 23 |
| Apparent total body clearance (CLT/F) | Up to Day 16 |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to Day 16 |
| Effective elimination half-life during dosing interval (T-HALF(eff)) | Up to Day 16 |
| Cmax Accumulation Index: Ratio of Cmax at steady state to Cmax after first dose (AI_Cmax) | Up to Day 16 |
| AUC(TAU) Accumulation Index: Ratio of AUC(TAU) at steady state to AUC(TAU) after first dose (AI_AUC) | Up to Day 16 |
Countries
United Kingdom
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed