A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses
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|ClinicalTrials.gov Identifier: NCT04118127|
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: 2mg conventional tablet, once-weekly tablets||Phase 1|
A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses.
The trial comprises the single-dose period (Cohort 1) and the multiple-dose period (Cohort 2). The dose used in the multiple-dose period (Cohort 2) will be determined based on plasma drug concentrations obtained in the single-dose period (Cohort 1).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open-label Clinical Pharmacology Trial to Investigate the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses in Patients With Schizophrenia|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
|Experimental: 2mg conventional tablet, once-weekly tablets||
Drug: 2mg conventional tablet, once-weekly tablets
In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.
- Plasma concentrations of brexpiprazole [ Time Frame: Blood Sampling for plasma drug measurement predose and 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118127
|Contact: Drug Information Center||+81-3-6361-7314|
|Sankeikai Nishigahara Hospital||Recruiting|
|Study Director:||Osamu Sato||Otsuka Pharmaceutical Co., Ltd.|