Trial Outcomes & Findings for Lurasidone Pediatric Pharmacokinetics Study (NCT NCT01620060)

NCT ID: NCT01620060

Last Updated: 2016-04-08

Results Overview

Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 105 participants
• Primary outcome timeframe: 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
• Results posted on: 2016-04-08

Participant Flow

Total subjects randomized was 105. Total subjects with PK data was 102.

Participant milestones

Measure	Lurasidone Oral Tablets Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Overall Study STARTED	105
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Lurasidone Oral Tablets Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Overall Study Adverse Event	9
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1
Overall Study Did not comply with Study Produre	1
Overall Study Family emergency	1
Overall Study Per Sponsor Decision	2

Baseline Characteristics

Lurasidone Pediatric Pharmacokinetics Study

Baseline characteristics by cohort

Measure	Lurasidone Oral Tablets n=105 Participants Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Age, Categorical <=18 years	105 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	23 participants n=5 Participants
Race/Ethnicity, Customized White	82 participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)

Outcome measures

Measure	Lurasidone Oral Tablets n=102 Participants Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Lurasidone Primary Pharmacokinetic Parameters AUC last (ng.h/mL) -Day 1 20 mg n=16	78 ng.h/mL Standard Deviation 44.9
Lurasidone Primary Pharmacokinetic Parameters AUC last (ng.h/mL) -Day 1 40 mg n=24	140 ng.h/mL Standard Deviation 65.4
Lurasidone Primary Pharmacokinetic Parameters AUC last (ng.h/mL) -Day 1 80 mg n=54	300 ng.h/mL Standard Deviation 140
Lurasidone Primary Pharmacokinetic Parameters AUC0-24 (ng.h/mL) -D 10/12 20 mg n=16	115 ng.h/mL Standard Deviation 72.2
Lurasidone Primary Pharmacokinetic Parameters AUC0-24 (ng.h/mL) -D10/12 40 mg n=21	154 ng.h/mL Standard Deviation 67.4
Lurasidone Primary Pharmacokinetic Parameters AUC0-24 (ng.h/mL) -D10/12 80 mg n=17	387 ng.h/mL Standard Deviation 194
Lurasidone Primary Pharmacokinetic Parameters AUC0-24 (ng.h/mL) -D10/12 120 mg n=16	494 ng.h/mL Standard Deviation 271
Lurasidone Primary Pharmacokinetic Parameters AUC0-24 (ng.h/mL) -D 10/12 160 mg n=13	590 ng.h/mL Standard Deviation 227
Lurasidone Primary Pharmacokinetic Parameters AUC0-∞(ng.h/mL) -D 1 20 mg n=16	83.8 ng.h/mL Standard Deviation 48.3
Lurasidone Primary Pharmacokinetic Parameters AUC0-∞(ng.h/mL) -D 1 40 mg n=19	153 ng.h/mL Standard Deviation 69.8
Lurasidone Primary Pharmacokinetic Parameters AUC0-∞(ng.h/mL) -D 1 80 mg n=50	328 ng.h/mL Standard Deviation 163

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Lurasidone Oral Tablets n=102 Participants Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-D10/12 120 mg n=16	94.2 ng/mL Standard Deviation 46.6
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-Day 1 20 mg n=16	24.4 ng/mL Standard Deviation 14.1
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-Day 1 40 mg n=24	38.3 ng/mL Standard Deviation 22.4
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-Day 1 80 mg n=55	68.2 ng/mL Standard Deviation 37.5
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-D10/12 20 mg n=16	30 ng/mL Standard Deviation 18
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-D10/12 40 mg n=21	36.2 ng/mL Standard Deviation 17.5
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-D10/12 80 mg n=17	80 ng/mL Standard Deviation 59.6
Lurasidone Peak Serum Concentration (Cmax) Cmax (ng/mL)-D10/12 160 mg n=13	99.7 ng/mL Standard Deviation 44.3

SECONDARY outcome

Timeframe: 11 Days

Serious adverse event and adverse events data will be listed and summarized as per MedDRA V15.0

Outcome measures

Measure	Lurasidone Oral Tablets n=105 Participants Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Number of Participants With Serious Adverse Events and Non-serious Adverse Events	105 participants

Adverse Events

Lurasidone Oral Tablets

Serious events: 2 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lurasidone Oral Tablets n=105 participants at risk Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Nervous system disorders Parkinsonism	0.95% 1/105 • Number of events 1 • June 19, 2012 through May 6, 2013
Nervous system disorders Dystonia	0.95% 1/105 • Number of events 1 • June 19, 2012 through May 6, 2013

Other adverse events

Measure	Lurasidone Oral Tablets n=105 participants at risk Lurasidone 20, 40, 80, 120 or 160 mg/day Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
Gastrointestinal disorders Nausea	17.1% 18/105 • Number of events 20 • June 19, 2012 through May 6, 2013
Gastrointestinal disorders Vomiting	15.2% 16/105 • Number of events 18 • June 19, 2012 through May 6, 2013
Gastrointestinal disorders Upper Abdominal Pain	5.7% 6/105 • Number of events 6 • June 19, 2012 through May 6, 2013
Nervous system disorders Somnelence	41.9% 44/105 • Number of events 104 • June 19, 2012 through May 6, 2013
Nervous system disorders Sedation	18.1% 19/105 • Number of events 35 • June 19, 2012 through May 6, 2013
Nervous system disorders Dystonia	4.8% 5/105 • Number of events 7 • June 19, 2012 through May 6, 2013
Nervous system disorders Dyskinesia	4.8% 5/105 • Number of events 5 • June 19, 2012 through May 6, 2013
Psychiatric disorders Anxiety	5.7% 6/105 • Number of events 6 • June 19, 2012 through May 6, 2013

Additional Information

Medical Director, CNS

Sunovion

Phone: 1-866-503-6351

Results disclosure agreements

• Principal investigator is a sponsor employee In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.
• Publication restrictions are in place

Restriction type: OTHER