At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 73 enrolled
Drug / intervention
2mg conventional tablet, once-weekly tabletsdrug
Likely dose
2mg conventional tablet, once-weekly tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating 2mg conventional tablet, once-weekly tablets for Schizophrenia. Completed, enrolled 73 participants across 1 site.
Detailed Summary
To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionFeb 2021
Study CompletionMar 2021
TodayJul 2026
First PostedOct 8, 2019
Enrollment StartOct 17, 2019
Primary CompletionFeb 16, 2021
Study CompletionMar 3, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.7 years ago
Interventions
2mg conventional tablet, once-weekly tabletsdrug
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.