Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder (NCT NCT04779177)

Results Overview

Maximum plasma concentration of lumateperone

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

Day 1 and Day 5

Results posted on

2025-11-12

Participant Flow

Lumateperone 42 mg once daily was evaluated in the study. Lumateperone 28 mg once daily was a potential dosage, however it was not evaluated in the study.

Participant milestones

Participant milestones
Measure	Lumateperone 42 mg Once Daily for 5 Days Lumateperone 42 mg: Lumateperone 42 mg, oral administration
Overall Study STARTED	26
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumateperone 42 mg Once Daily for 5 Days n=26 Participants Lumateperone 42 mg: Lumateperone 42 mg, oral administration
Age, Continuous	15.2 years STANDARD_DEVIATION 1.41 • n=10 Participants
Sex: Female, Male Female	11 Participants n=10 Participants
Sex: Female, Male Male	15 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	26 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 5

Population: The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC.

Maximum plasma concentration of lumateperone

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg Once Daily for 5 Days n=25 Participants Lumateperone 42 mg: Lumateperone 42 mg, oral administration
Pharmacokinetics: Cmax Day 1	19.12 ng/mL Standard Deviation 11.21
Pharmacokinetics: Cmax Day 5	23.22 ng/mL Standard Deviation 12.60

PRIMARY outcome

Timeframe: Day 1 and Day 5

Population: The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC.

Time of maximum concentration of lumateperone in plasma

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg Once Daily for 5 Days n=25 Participants Lumateperone 42 mg: Lumateperone 42 mg, oral administration
Pharmacokinetics: Tmax Day 1	1.000 h Interval 0.25 to 6.0
Pharmacokinetics: Tmax Day 5	1.000 h Interval 0.5 to 4.0

PRIMARY outcome

Timeframe: 0 to 24 hours post-dose on Day 1 and Day 5

Population: The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC.

Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg Once Daily for 5 Days n=25 Participants Lumateperone 42 mg: Lumateperone 42 mg, oral administration
Pharmacokinetics: AUC0-t Day 1	43.612 h*ng/mL Standard Deviation 21.404
Pharmacokinetics: AUC0-t Day 5	54.975 h*ng/mL Standard Deviation 26.992

PRIMARY outcome

Timeframe: 0 to 24 hours post-dose on Day 1 and Day 5

Population: The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC.

Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg Once Daily for 5 Days n=22 Participants Lumateperone 42 mg: Lumateperone 42 mg, oral administration
Pharmacokinetics: AUC0-tau Day 1	48.158 h*ng/mL Standard Deviation 20.899
Pharmacokinetics: AUC0-tau Day 5	58.437 h*ng/mL Standard Deviation 27.792

PRIMARY outcome

Timeframe: Day 1 and Day 5

Population: The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC.

Terminal elimination half-life of lumateperone

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg Once Daily for 5 Days n=21 Participants Lumateperone 42 mg: Lumateperone 42 mg, oral administration
Pharmacokinetics: t1/2 Day 1	2.208 h Standard Deviation 0.6162
Pharmacokinetics: t1/2 Day 5	2.681 h Standard Deviation 1.092

PRIMARY outcome

Timeframe: Day 1 and Day 5

Population: The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC.

Apparent oral clearance of lumateperone