A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBristol-Myers Squibb
About this trial
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) criteria and Mini International Neuropsychiatric Interview (MINI) (version 7.0.2).
Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4 at both screening and baseline.
Participants must have a body mass index (BMI) between 18 and 40 kg/m².
Participants should be willing and able, as determined by the investigator, to discontinue all antipsychotic medications prior to the baseline visit and must be able to comply with all protocol requirements.
Disqualifiers
Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia.
Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder.
Participants must not have a history of alcohol or drug use disorder within the past 12 months or those with clinically significant disease or disorder that would jeopardize their safety or affect the validity of study results.
Participants must not be at risk for suicidal behavior.
Trial design
Design model
Sequential
Treatments tested in this trial
KarXT
DrugSpecified dose on specified days
Treatment groups
116 Participants
are divided into 1 treatment groupGroup A: Administration of KarXTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AEs)
Time frame
Up to 3 weeks2
Number of participants with adverse events of special interest (AESIs)
Time frame
Up to 3 weeks3
Number of participants with serious adverse events (SAEs)
Time frame
Up to 3 weeksSecondary outcomes
1
Maximum concentration (Cmax)
Time frame
Up to 15 weeks2
Time to maximum concentration (Tmax)
Time frame
Up to 15 weeks3
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame
Up to 15 weeks4
Area under the plasma concentration-time curve from time zero to infinity (AUC(INF))
Time frame
Up to 15 weeksSponsors and contacts
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Source ClinicalTrials.gov