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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163351 | Other Identifier | Japic |
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The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-34712 disintegrating tablet with water | Experimental | OPC-34712 (4 mg) orally disintegrating tablet is administered with water. |
|
| OPC-34712 disintegrating tablet without water | Experimental | OPC-34712 (4 mg) orally disintegrating tablet is administered without water. |
|
| OPC-34712 conventional tablet with water | Experimental | OPC-34712 (4 mg) conventional tablet is administered with water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-34712 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of OPC-34712 | To evaluate Cmax of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation | Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) of OPC-34712 | To evaluate AUC∞ of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation | Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Ono, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyusyu Region | Japan |
A total of 33 subjects were screened for participation in this trial. Of the 33 subjects, 18 subjects were enrolled and randomized to one of 3 sequences, each consisting of 6 subjects. Of the 6 subjects in the Sequence 1 group, 6 subjects received a single dose of OPC-34712 orally disintegrating tablet (ODT) without water, 5 subjects received a single dose of OPC-34712 conventional tablet, and 4 subjects received a single dose of OPC-34712 ODT with water.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Subjects randomized to Sequence 1 received an ODT without water on Day 1, a conventional tablet on Day 21, and an ODT with water on Day 41. |
| FG001 | Sequence 2 | Subjects randomized to Sequence 2 received an ODT with water on Day 1, an ODT without water on Day 21, and a conventional tablet on Day 41. |
| FG002 | Sequence 3 | Subjects randomized to Sequence 3 received a conventional tablet on Day 1, an ODT with water on Day 21, and an ODT without water on Day 41. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Subjects randomized to Sequence 1 received an ODT without water on Day 1, a conventional tablet on Day 21, and an ODT with water on Day 41. |
| BG001 | Sequence 2 | Subjects randomized to Sequence 2 received an ODT with water on Day 1, an ODT without water on Day 21, and a conventional tablet on Day 41. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of OPC-34712 | To evaluate Cmax of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation | Pharmacokinetic analysis set consisted of subjects with all evaluable PK parameters from enrolled subjects who had evaluable plasma concentrations. No data imputation was done for missing data, ie, missing data remained missing for the analyses. | Posted | Mean | Standard Deviation | ng/mL | Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose |
|
From the start of IMP administration throughout follow-up period (up to 22 days after the last dose of IMP)
A treatment-emergent adverse event (AE) was defined as an AE that started after start of IMP, or an AE that continued from baseline and became serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of trial medication. The safety analysis dataset included all subjects that were administered at least one dose of IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPC-34712 Disintegrating Tablet With Water | OPC-34712 (4 mg) orally disintegrating tablet is administered with water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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| BG002 | Sequence 3 | Subjects randomized to Sequence 3 received a conventional tablet on Day 1, an ODT with water on Day 21, and an ODT without water on Day 41. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
OPC-34712 (4 mg) orally disintegrating tablet is administered without water. |
| OG002 | OPC-34712 Conventional Tablet With Water | OPC-34712 (4 mg) conventional tablet is administered with water. |
|
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| Primary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) of OPC-34712 | To evaluate AUC∞ of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation | Pharmacokinetic analysis set consisted of subjects with all evaluable PK parameters from enrolled subjects who had evaluable plasma concentrations. No data imputation was done for missing data, ie, missing data remained missing for the analyses. | Posted | Mean | Standard Deviation | ng·h/mL | Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 8 |
| 16 |
| EG001 | OPC-34712 Disintegrating Tablet Without Water | OPC-34712 (4 mg) orally disintegrating tablet is administered without water. | 0 | 18 | 0 | 18 | 7 | 18 |
| EG002 | OPC-34712 Conventional Tablet With Water | OPC-34712 (4 mg) conventional tablet is administered with water. | 0 | 17 | 0 | 17 | 9 | 17 |
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
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