A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)

Phase 1

Completed

• Conditions: Schizophrenia; Bipolar I Disorder
• Interventions: Drug: Asenapine 10 mg; Drug: Asenapine 2.5 mg; Drug: Asenapine 5 mg

• Registration Number: NCT01206517
• Lead Sponsor: Organon and Co

Brief Summary

This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be enrolled. Participants will receive a single sublingual placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12 (Cohort 3a).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-18
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2011-08-04
• Study Completion: 2011-08-04
• Results First Submitted: 2012-11-20
• Results First Submitted QC: 2012-11-20
• Results First Posted: 2012-12-21
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3a-d	Asenapine 10 mg	Cohort 3a: Participants 10 or 11 years of age Cohort 3b: Participants 12 or 13 years of age Cohort 3c: Participants 14 or 15 years of age Cohort 3d: Participants 16 or 17 years of age
Cohort 1	Asenapine 2.5 mg	Participants 10 or 11 years of age
Cohort 2	Asenapine 5 mg	Participants 10 or 11 years of age

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Asenapine	Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)	Cmax is the peak plasma concentration following a dose of the study drug.
Time to Maximum Plasma Concentration (Tmax) of Asenapine	Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)	tmax is the time from dosing to maximum plasma drug concentration levels.
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine	Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)	AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.
Terminal Phase (Elimination) Half-life (t1/2) of Asenapine	Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)	Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.