Trial · NCT01620060

Lurasidone Pediatric Pharmacokinetics Study

NCT01620060, Phase 1, Completed, Sumitomo Pharma America, Inc.; results first posted 2014-07-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lurasidone Pediatric Pharmacokinetics Study. Trials, record NCT01620060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01620060

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lurasidone Pediatric Pharmacokinetics Study
NCT number: NCT01620060
Status: Completed
Phases: Phase 1
Enrollment: 105 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Schizophrenia, Autism
Interventions: Lurasidone
First posted: 2012-06-15
Last updated: 2016-04-08
Results first posted: 2014-07-31

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Lurasidone Primary Pharmacokinetic Parameters	Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours	Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)
Primary	Lurasidone Peak Serum Concentration (Cmax)	Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours	Cmax will be listed and summarized in tabular format
Secondary	Number of Participants With Serious Adverse Events and Non-serious Adverse Events	11 Days	Serious adverse event and adverse events data will be listed and summarized as per MedDRA V15.0

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Lurasidone Primary Pharmacokinetic Parameters	Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours	Participants for PK analysis included all subjects who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK timepoint after start of dosing for at least 1 PK analyte.~For some PK parameters, some subjects didn't have PK data.	ng.h/mL	MEAN
PRIMARY	Lurasidone Peak Serum Concentration (Cmax)	Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours		ng/mL	MEAN
SECONDARY	Number of Participants With Serious Adverse Events and Non-serious Adverse Events	11 Days		participants	NUMBER

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC last (ng.h/mL) -Day 1 20 mg n=16	78	Standard Deviation 44.9	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC last (ng.h/mL) -Day 1 40 mg n=24	140	Standard Deviation 65.4	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC last (ng.h/mL) -Day 1 80 mg n=54	300	Standard Deviation 140	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC0-24 (ng.h/mL) -D 10/12 20 mg n=16	115	Standard Deviation 72.2	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC0-24 (ng.h/mL) -D10/12 40 mg n=21	154	Standard Deviation 67.4	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC0-24 (ng.h/mL) -D10/12 80 mg n=17	387	Standard Deviation 194	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC0-24 (ng.h/mL) -D10/12 120 mg n=16	494	Standard Deviation 271	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC0-24 (ng.h/mL) -D 10/12 160 mg n=13	590	Standard Deviation 227	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC0-∞(ng.h/mL) -D 1 20 mg n=16	83.8	Standard Deviation 48.3	ng.h/mL
Lurasidone Primary Pharmacokinetic Parameters	Lurasidone Oral Tablets	AUC0-∞(ng.h/mL) -D 1 40 mg n=19	153	Standard Deviation 69.8	ng.h/mL

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lurasidone Oral Tablets	105
Overall Study	COMPLETED	Lurasidone Oral Tablets	90
Overall Study	NOT COMPLETED	Lurasidone Oral Tablets	15

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Lurasidone Oral Tablets	18	105	20
other	Vomiting	Gastrointestinal disorders	Lurasidone Oral Tablets	16	105	18
other	Upper Abdominal Pain	Gastrointestinal disorders	Lurasidone Oral Tablets	6	105	6
other	Somnelence	Nervous system disorders	Lurasidone Oral Tablets	44	105	104
other	Sedation	Nervous system disorders	Lurasidone Oral Tablets	19	105	35
other	Dystonia	Nervous system disorders	Lurasidone Oral Tablets	5	105	7
other	Dyskinesia	Nervous system disorders	Lurasidone Oral Tablets	5	105	5
other	Anxiety	Psychiatric disorders	Lurasidone Oral Tablets	6	105	6
serious	Parkinsonism	Nervous system disorders	Lurasidone Oral Tablets	1	105	1
serious	Dystonia	Nervous system disorders	Lurasidone Oral Tablets	1	105	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lurasidone Oral Tablets
Total, other adverse events	Lurasidone Oral Tablets	76	105
Total, serious adverse events	Lurasidone Oral Tablets	2	105

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26631428	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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