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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Quotient Sciences
Nottingham, Nottinghamshire, United Kingdom
RECRUITINGMaximum observed concentration (Cmax)
Time frame: Up to Day 23
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 23
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 23
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 23
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to Day 23
Concentration at the end of a dosing interval (Ctau)
Time frame: Up to Day 23
Apparent total body clearance (CLT/F)
Time frame: Up to Day 23
Effective elimination half-life during dosing interval (T-HALF(eff))
Time frame: Up to Day 23
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
Time frame: Up to 30 days after final dose of study intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 14
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
Time frame: Up to 30 days after final dose of study intervention
Number of participants with vital signs abnormalities
Time frame: Up to 30 days after final dose of study intervention
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 30 days after final dose of study intervention
Number of participants with physical examination abnormalities
Time frame: Up to 30 days after final dose of study intervention
Number of participants with clinical laboratory abnormalities
Time frame: Up to 30 days after final dose of study intervention
Geometric mean ratio of Cmax
Time frame: Up to Day 12
Geometric mean ratio of AUC(0-T)
Time frame: Up to Day 12
Geometric mean ratio of AUC(INF)
Time frame: Up to Day 12
Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU))
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to Day 12
Maximum observed concentration (Cmax)
Time frame: Up to Day 16
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 16
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 16
Area under the plasma concentration-time curve from time zero to 12 hours (AUC(0-12))
Time frame: Up to Day 4
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 23
Apparent total body clearance (CLT/F)
Time frame: Up to Day 16
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to Day 16
Effective elimination half-life during dosing interval (T-HALF(eff))
Time frame: Up to Day 16
Cmax Accumulation Index: Ratio of Cmax at steady state to Cmax after first dose (AI_Cmax)
Time frame: Up to Day 16
AUC(TAU) Accumulation Index: Ratio of AUC(TAU) at steady state to AUC(TAU) after first dose (AI_AUC)
Time frame: Up to Day 16