Study to Assess Safety and Effectiveness of Slowly Increa... | NCT06572449

NCT06572449

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
KarXT on empty stomach and with food	Experimental		Drug: KarXT

Name	Type	Description	Arm Group Labels	Other Names
KarXT	Drug	Specified dose on specified days	KarXT on empty stomach and with food

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With TEAEs From First Dose to End of Study Follow up.	Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.	From first dose to end of study follow up (63 days)
Number of Participants With TEAEs at the End of Period 1 and Period 2.	Number of participants with TEAEs at the end of period 1 and period 2. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.	Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)
Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.	Number of participants with TEAEs at the end of period 1 and period 2. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.	Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
Number of Participants With TEAEs Leading to Treatment Discontinuation.	Number of participants with TEAEs leading to treatment discontinuation.

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in PANSS Total Score, Positive Score and Negative Score	The Positive and Negative Syndrome Scale (PANSS) assesses schizophrenia symptom severity using 30 items: 7 positive, 7 negative, and 16 general psychopathology scales. Each item is rated from 1 (absent) to 7 (extreme). Positive symptoms represent excesses or distortions of normal function (e.g., hallucinations, delusions), while negative symptoms reflect diminished function. The PANSS positive and negative scores each sum their respective 7 items, ranging from 7 to 49, with higher scores indicating greater severity. The PANSS Total Score sums all 30 items, ranging from 30 to 210, with higher scores reflecting worse overall symptom severity.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0002		Los Alamitos	California	90720-3118	United States
Local Institution - 0004

References Module

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 18, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
BG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000100 BG00173 BG002173

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00120 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00018 BG00114 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Change From Baseline in PANSS Total Score, Positive Score and Negative Score

The Positive and Negative Syndrome Scale (PANSS) assesses schizophrenia symptom severity using 30 items: 7 positive, 7 negative, and 16 general psychopathology scales. Each item is rated from 1 (absent) to 7 (extreme). Positive symptoms represent excesses or distortions of normal function (e.g., hallucinations, delusions), while negative symptoms reflect diminished function. The PANSS positive and negative scores each sum their respective 7 items, ranging from 7 to 49, with higher scores indicating greater severity. The PANSS Total Score sums all 30 items, ranging from 30 to 210, with higher scores reflecting worse overall symptom severity.

All Treated Participants with measurement at end of treatment

Posted

Mean

Standard Deviation

Score on a Scale

From first dose to end of treatment (56 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Units	Counts
Participants	OG00096 OG00168

Title

Denominators

Categories

Total Score

Title	Measurements
	OG000-3.9± 8.98 OG001-2.7± 7.40

Positive Score

Title	Measurements
	OG000

Secondary

Change From Baseline in Marder Factor Score.

PANSS Marder factor score is the sum of 5 negative scales and 2 general scales (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance). Participants are rated from 1 to 7 on each symptom scale, with a total score ranging from 7 to 49. Higher score indicates more severe symptoms. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Baseline is defined as the PANSS score at screening.

All Treated Participants with measurement at end of treatment

Posted

Mean

Standard Deviation

Score on a Scale

From first dose to end of treatment (56 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Secondary

Change From Baseline in CGI Severity Score

Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days. Higher score indicates more severe illness.

All Treated Participants with measurement at end of treatment

Posted

Mean

Standard Deviation

Score on a Scale

From first dose to end of treatment (56 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Secondary

Number of Participants With Spontaneously Reported AESIs

The AEs of special interest (AESIs) will be monitored and include symptomatic orthostasis, syncope(a transient loss of consciousness or fainting),and liver function test elevations as defined below. For SAE reporting requirements for events of liver injury.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to end of study follow up (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Secondary

Number of Participants With Clinically Significant Changes in Vital Signs

Number of participants with clinically significant changes in vital signs

All Treated Participants

Posted

Count of Participants

Participants

From first dose to end of study follow up (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Number of participants with clinically significant changes in clinical laboratory assessments

All Treated Participants

Posted

Count of Participants

Participants

From first dose to end of study follow up (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Units	Counts

Secondary

Number of Participants With Clinically Significant Changes in 12-lead ECGs

Number of participants with clinically significant changes in 12-lead ECGs

All Treated Participants

Posted

Count of Participants

Participants

From first dose to end of study follow up (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Units	Counts
Participants

Secondary

Number of Participants Who Exhibited Suicidal Behavior as Assessed by C-SSRS

Number of participants who exhibited suicidal behavior as assessed by C-SSRS

All Treated Participants

Posted

Count of Participants

Participants

From first dose to end of study follow up (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Units	Counts
Participants

Primary

Number of Participants With TEAEs From First Dose to End of Study Follow up.

Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up.

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to end of study follow up (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Primary

Number of Participants With TEAEs at the End of Period 1 and Period 2.

Number of participants with TEAEs at the end of period 1 and period 2.

All Treated Participants

Posted

Count of Participants

Participants

Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Primary

Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.

Number of participants with TEAEs at the end of period 1 and period 2.

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

All Treated Participants

Posted

Count of Participants

Participants

Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Primary

Number of Participants With TEAEs Leading to Treatment Discontinuation.

Number of participants with TEAEs leading to treatment discontinuation.

All Treated Participants

Posted

Count of Participants

Participants

Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Units	Counts

Primary

Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.

The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.

All Treated Participants

Posted

Count of Participants

Participants

Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

ID	Title	Description
OG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.
OG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1	Period 1: Days 1-7 (Week 1)-KarXT 50/20 BID Days 8-14 (Week 2)-KarXT 100/20 BID Days 15-28 (Week 3-Week 4) -KarXT 125/30 BID Period 2: On Day 29 (start of Week 5) participants will receive the same KarXTdose as Day 28 (last day of Week 4) BID During Period 2, participants will have the option to dose de-escalate one time from 125/30BID to 100/20 BID depending on tolerability as assessed by the investigator. Dose escalation will not be permitted during Period 2.	0	100	0	100	54	100
EG001	Cohort 2	Period 1: Days 1-7 (Week 1) -KarXT 50/20 BID Days 8-28(Week 2-Week 4) -KarXT 100/20 BID Period 2: On Day 29 (start of Week 5), participants will receive the same KarXT dose as Day 28 (last day of Week 4) BID Dose escalation will not be permitted during Period 2.	0	73	0	73	44	73

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 affected100 at risk EG0012 affected73 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00013 affected100 at risk EG00112 affected73 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00019 affected100 at risk EG00116 affected73 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 affected100 at risk EG0018 affected73 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00030 affected100 at risk EG00117 affected73 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00017 affected100 at risk EG00113 affected73 at risk
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0007 affected100 at risk EG0015 affected73 at risk
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00013 affected100 at risk EG00116 affected73 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected100 at risk EG0014 affected73 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 affected100 at risk EG0012 affected73 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected100 at risk EG0015 affected73 at risk

First MCP Posted Date

ID	Term
D012559	Schizophrenia
D004194	Disease
D001523	Mental Disorders

Units	Counts
Participants	OG000100 OG00173

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms